Registration Dossier

Administrative data

Description of key information

Studies of skin and eye irritation in vivo are available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Very little information provided on the materials and methods of the study. RRead across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier. Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.
Justification for type of information:
Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids. This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier. Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Not stated
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No details
Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
The test material was applied undiluted to the belly of the rabbits and left uncovered
Duration of treatment / exposure:
Not stated
Observation period:
Not stated
Number of animals:
Not stated
Details on study design:
No details provided for exposure of rabbits for the assessment of skin irritation. The results tabulation indicates open application to the belly of rabbits but does not detail the number of animals, preparation of the test site, means or duration of application. The method of assessing reactions is also not specified
Irritation parameter:
other:
Basis:
mean
Time point:
other: No data
Score:
2
Reversibility:
no data
Remarks on result:
other: The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2. No details of the method of assessment are given and no means of correlating the result with erythema or oedema reactions.
Irritant / corrosive response data:
The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2. No details of the method of assessment are given and no means of correlating the result with erythema or oedema reactions.
Other effects:
No data

Toxicity

A wide range of toxicity and irritation of epoxy monomers is documented in this report. No consistent correlations with structure are evident.

Carcinogenicity

The test was successfully completed. The test material was not considered to be tumorigenic to the mouse skin.

Sebaceous Gland Suppression

The mena number of sebaceous glands per square centimeter of skin of epoxide-dosed mice has been graded against that of the control mice. As the material was applied undiluted, it was compared to a distilled water control group. This substance was tested by both the sebaceous gland (S.G.T.) and the lifetime tests (L.T.T.). The L.T.T. was negative, the tumour and the cancer index were both 0.0. It was given a S.G.T. grade of 0.

The authors of this report have indicated that the S.G.T., based on the data in this report, is merely a crude screen to indicate potential L.T.T. tumorigens, not a test to be used to from definite positive or negative conclusions concerning tumorigenesis.

Interpretation of results:
study cannot be used for classification
Conclusions:
Irritation
The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2.
Executive summary:

Read across to ESBO results are justified for ELO on basis of similar function and structure. The suporting information relating to in vivo irritation reported in this study is applied to ELO.

Carcinogenic and acute toxicity potential of the test material was assayed.

Irritation

The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2.

Toxicity

A wide range of toxicity and irritation of epoxy monomers is documented in this report. No consistent correlations with structure are evident.

Carcinogenicity

The test was successfully completed. The test material was not considered to be tumorigenic to the mouse skin.

Sebaceous Gland Suppression

The mena number of sebaceous glands per square centimeter of skin of epoxide-dosed mice has been graded against that of the control mice. As the material was applied undiluted, it was compared to a distilled water control group. This substance was tested by both the sebaceous gland (S.G.T.) and the lifetime tests (L.T.T.). The L.T.T. was negative, the tumour and the cancer index were both 0.0. It was given a S.G.T. grade of 0.

The authors of this report have indicated that the S.G.T., based on the data in this report, is merely a crude screen to indicate potential L.T.T. tumorigens, not a test to be used to from definite positive or

Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
10 August 1981 to 17 August 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The experimental design is similar to that of OECD guideline 404 with enhanced exposure due to an extended exposure period - 24 hours - and inclusion of dermal abrasion prior to application of the test material. Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier. Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.
Justification for type of information:
Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids. This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier. Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.
Qualifier:
equivalent or similar to
Guideline:
other: Proposed Guidelines of the United States Environmental Agency (EPA) S 163.81-5 "Primary dermal irritation study" Federal Register, Vol. 43, No. 163, August 22, 1978
Deviations:
yes
Remarks:
Exposure period was for 24 hours rather than 4 hours as currently required for assessment of irritation
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the laboratory premises. They weighed 2 - 3 Kgs.

They were housed individually in metal cages numbered by ear tags.
They were kept at constant room temperature of 22 ± 2 °C, at a relative humidity of 55 ± 10 % and on a 12-hours light cycle day.
The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water.
Prior to treatment they were adapted to the laboratory for a minimum of 4 days.
Type of coverage:
occlusive
Preparation of test site:
other: skin was shaved. One site abraded one left unabraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Gauze patches of 2.5 x 2.5 cm laden with 0.5 mL of the test material were applied to the prepared abraded and intact skin.

The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
Duration of treatment / exposure:
The dressings were removed after a 24 hour application.
Observation period:
The skin reaction was appraised using standard Draize assessment, on removal of dressing and during an observation period of 7 days.
Number of animals:
3 male and 3 female adult New Zealand White rabbits
Details on study design:
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaved skin on one side was lightly sacrified using a scalpel blade.

Gauze patches of 2.5 x 2.5 cm laden with 0.5 mL of the test material were applied to the prepared abraded and intact skin. The patches were covereed with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

The skin reaction was appraised on ths basis of the following evaluation scheme:

Score for skin irritation in rabbits:

Erythema and eschar formation:
No erythema: .................................................................... 0
Very slight erythema (barely perceptible):.................... 1
Well defined erythema:..................................................... 2
Moderate to severe erythema:........................................ 3
Severe erythema (beet redness) to slight eschar
formation {injuries in depth) :......................................... 4

Total possible erythema score:...................................... 4

Oedema formation
No edema: .......................................................................0
Very sllght edema (barely perceptible): ..................... 1
Sllght edema (edges of area well defined by
definite raising):............................................................. 2
Moderate edema (raised approximately 1 mm): ...... 3
Severe edema {raised more than 1 mm and
extending beyond area of exposure): ........................4

Total possible oedema score: ........................................ 4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h post application
Max. score:
1.7
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Only limited information is provided relating to 24 and 72 scores. Reversibility is presented graphically
Irritant / corrosive response data:
The results of the primary skin irritation test are reported in Table 1.

Tha calculated primary irritation index was 2.6 - this includes results from abraded and non-abraded skin.
TK 11'278 was found to cause a moderate irritation when applied to intact and abraded rabbit skin, according to the interpretation of PII results

After 24 hours the surface of the erythema was greater than the site of application on all sites except No. 415 (intact) and No. 416 (abraded). This observation was made after 48 hours on both sites of animal No. 417 and after 72 hours on the abraded side of the same animal.

Results were revaluated to determine a possble classification in accordance with EU/GHS criteria.

In the absence of individual animal scores, taking into account the extended exposure period and assuming a linear response for ameliorating dermal responses between 24 and 72 hours, the mean results for non-abraded skin were averaged for 24 and 72 hour responses as an approximation of the Draize result. On this basis, the mean erythema score for non-abraded skin over 24-72 h was 1.5 and for oedema the mean result was 0.75.
Neiher of these values exceeds the EU classification threshold.
Other effects:
With the exception of the last day of the test, a slight sedation was observed.

Table 1       Calculation of the primary skin irritation index

Time after exposure (hours)

Mean Reaction Score

Erythema

Oedema

Intact Skin

Abraded Skin

Intact Skin

Abraded Skin

24

1.7

2.0

1.0

1.5

72

1.3

1.5

0.5

0.7

 

Total

3.0

3.5

1.5

2.2

Assessment of Irritation

0

0.1 - 1.0 = minimal

1.1 - 2.0 = slight

2.1 - 4.0 = moderate

4.1 - 6.0 = marked

6.1 - 8.0 = extreme

The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. The primary irritation index was 2.6.

The abraded skin results are not appropriate for assessment under EU classification guidelines. The mean scores are 24 and 72 hours were used as approximations to the 24 -72h mean. Erythema and oedema mean scores were approximated to be 1.5 and 0.75 respectively. Neither results exceeds the EU classification threshold

Interpretation of results:
GHS criteria not met
Conclusions:
Under the condition of the present experiment TK 11'278 was found to cause a moderate irritation when applied to intact and abraded rabbit skin.

The calculated primary irritation index was 2.6, based on a combined assessment of abraded and non-abraded skin exposed for 24 hours.

The abraded skin results are not appropriate for assessment under EU classification guidelines. The mean scores are 24 and 72 hours were used as approximations to the 24 -72h mean. Erythema and oedema mean scores were approximated to be 1.5 and 0.75 respectively. Neither results exceeds the EU classification threshold. It is quite likely that the reactions observed were exacerbated by the prolonged exposure and so the estimated mean values are conservative estimates of irritating potential.
Executive summary:

Under the condition of the present experiment TK 11'278 was found to cause a moderate irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 2.6. The estimation of the mean score for irritation based on the 24 and 72 hour assessments was circa 1.0. According to Regulation (EC) No. 1272/2008, no classification is warranted.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
10 August 1981 - 24 August 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group.This study meets the criteria laid out in OECD Guideline 405. Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier. Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.
Justification for type of information:
Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids. This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier. Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Procedure used was that described in the Proposed Guideline of the United States Environmental Protection Agency (EPA) S 163.81 - 4 "Primary eye irritation study", Federal Register Vol. 43, No. 163, August 2, 1978 that were in draft at time of study conduct and subsequently adopted.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 6 female New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at constant room temperature of 22 ± 2°C, at a relative humidity of 55 ± 10% and on a 12 hour light cycle day. The animals had ad libitum access to standard rabbit food and water.

Prior to treatment they were adapted to the laboratory for a minimum of 4 days. Only rabbits with normal opthalmic findings were used for these tests
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of each rabbit served as the inherent control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
In three of the nine rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
9 - three rinsed and six not rinsed after installation
Details on study design:
0.1 mL of undiluted test material was instilled into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In three of the nine rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4, 7, 10 and 14 and was scored for each individual rabbit.

As the test compound is not soluble in water, an assessment of pH was not performed prior to dosing.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
not relevant
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other:
Remarks:
not relevant
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.06
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
Day 10
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.56
Max. score:
3
Reversibility:
fully reversible
Remarks:
Day 4
Irritant / corrosive response data:
The ocular reactions were assessed by the Kay and Callendra system, from which a PII was derived. For classification purposes the results were re-calculated using a standard Draize score deriving a mean for the reactions over 24-72 hours.
On this basis the mean results for the rinsed eyes (scores for six rabbits) were -
corneal opacity = 0.0
Iris response = 0.0
Conjunctival redness = 1.06
Conjunctival swelling/chemosis = 0.61
and for the rinsed eyes the mean values for 24-72 hours were:
corneal opacity = 0.0
Iris response = 0.0
Conjunctival redness = 0.89
Conjunctival swelling/chemosis = 0.56.
No corneal or iridial changes were evident for any of the nine rabbits. Conjunctival irritation did not exceed diffuse crimson coloration and had resolved in all unrinsed rabbits by Day 10. reactions persisted for one of the rinsed eyes to Day 14. Conjunctival chemosis had largely resolved by Day 4 for all nine rabbits although slight reactions persisted for one, unrinsed, eye to Day 7.
Other effects:
No symptoms of systemic intoxication were observed throughout the whole test period.

Table: 1 Calculation of the primary eye irritation index

Time after exposure days

Mean reaction score

Unrinsed eyes (A)

Rinsed eyes (B)

Cornea

iris

conjunctiva

cornea

iris

conjunctiva

1

0

0

4.7

0

0

3.3

2

0

0

3.3

0

0

2.7

3

0

0

2

0

0

2.7

4

0

0

1.3

0

0

1.3

7

0

0

1

0

0

0.7

10

0

0

0

0

0

0.7

14

0

0

0

0

0

0.7

The ocular reactions were assessed by the Kay and Callendra system, from which a PII was derived. For classification purposes the results were re-calculated using a standard Draize score deriving a mean for the reactions over 24-72 hours. On this basis the mean results for the rinsed eyes (scores for six rabbits) were - corneal opacity = 0.0 Iris response = 0.0 Conjunctival redness = 1.06 Conjunctival swelling/chemosis = 0.61 and for the rinsed eyes the mean values for 24-72 hours were: corneal opacity = 0.0 Iris response = 0.0 Conjunctival redness = 0.89 Conjunctival swelling/chemosis = 0.56. No corneal or iridial changes were evident for any of the nine rabbits. Conjunctival irritation did not exceed diffuse crimson coloration and had resolved in all unrinsed rabbits by Day 10. reactions persisted for one of the rinsed eyes to Day 14. Conjunctival chemosis had largely resolved by Day 4 for all nine rabbits although slight reactions persisted for one, unrinsed, eye to Day 7.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this experiement, the test material was found to cause slight conjunctival irritiation when applied to the rabbit eye mucosa:
Unrinsed eyes:
No irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean acore of 4.7 after 24 hours. After 10 days all irritation had disappeared.

Rinsed eyes:
No irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean score of 3.3 after 24 hours. After 7 days onwards only one of the three animals had a slight conjunctival redness. No symptoms of systemic intoxication were observed throughout the whole test period. According to Regulation (EC) No. 1272/2008, no classification is warranted.
Executive summary:

The test was performed on three male and six female New Zealand White rabbits. The test material was found to cause the following irritiation when applied to the rabbit eye mucosa: In the unrinsed eyes no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean acore of 4.7 after 24 hours. After 10 days all irritation had disappeared. In the rinsed eyes, no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean score of 3.3 after 24 hours. After 7 days onwards only one of the three animals had a slight conjunctival redness. No symptoms of systemic intoxication were observed throughout the whole test period.

Reactions were re-assessed using EU classification criteria and responses were confirmed as not exceeding the EU thresholds for triggering classification of an ocular irritant.

Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Very little information provided on the materials and methods of the study. Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier. Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.
Justification for type of information:
Epoxidised soybean oil (EC 232-391-0; CAS number 8013-07-8) is derived by epoxidation of soya bean oil. It is therefore considered to be a UVCB sub-type 1 material, since it is a modification of a substance of biological origin. Soya bean oil is a mixture of triglycerides (including linoleic [43-58%]; oleic [15-33%] and linolenic [5-12%] acids as the major fatty acid components. Epoxidation at some or all points of unsaturation (double bonds) in the fatty acid chains results in the epoxidised forms that are collectively known as epoxidised soybean oil (ESBO). Specifications, within the variations of possible ESBO combinations, are normally defined in terms of epoxidation number, oxirane oxygen content and iodine number. The first two being a reflection of the degree of epoxidation and the latter is a measure of the number of residual unsaturated double bonds. Given the nature of the epoxidation process, the final ESBO product may vary within the bounds of the degree of epoxidation and the mix of triglyceride content. In its evaluation of epoxidised oils and derivatives the OECD SIDS conclusion indicates epoxidised fatty acid esters can be assumed to follow similar metabolic pathways to those of other vegetable oils since the primary constituents of the metabolic products are similar. Based on structural, functional and metabolic similarities the primary epoxidised oils (including ESBO, ELO and ETP) can be considered within one functional category (see OECD SIDS for epoxidised oils and derivatives http://www.inchem.org/documents/sids/sids/Epoxidized-oils.pdf for further justification of category). Four epoxidised oils and derivatives form the Epoxidised Oils and Derivatives (EOD) Category based on structural and functional similarity.
Qualifier:
no guideline followed
Principles of method if other than guideline:
No information provided to determine methods used to assess ocular irritation - the results indicate that only corneal injury was assessed and other parameters normally included in current guidelines (e.g. iris and conjunctival responses) were not assessed.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data supplied
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
No details are provided to determine how rabbit ocular injury was assessed. No methodological information was available.
Duration of treatment / exposure:
No details for duration of exposure
Observation period (in vivo):
No data
Number of animals or in vitro replicates:
No data
Details on study design:
No details supplied in report publication
Irritation parameter:
cornea opacity score
Basis:
other: the basis for the ocular score is not stated in publication
Time point:
other: No details provided
Score:
1
Reversibility:
not specified
Remarks on result:
other: The value for ocular injury cannot be interpreted since no details are provided for its derivation
Irritant / corrosive response data:
Corneal injury score of 1 recorded

Toxicity

A wide range of toxicity and irritation of epoxy monomers is documented in this report. No consistent correlations with structure are evident.

Carcinogenicity

The test was successfully completed. The test material was not considered to be tumorigenic to the mouse skin.

Sebaceous Gland Suppression

The mena number of sebaceous glands per square centimeter of skin of epoxide-dosed mice has been graded against that of the control mice. As the material was applied undiluted, it was compared to a distilled water control group. This substance was tested by both the sebaceous gland (S.G.T.) and the lifetime tests (L.T.T.). The L.T.T. was negative, the tumour and the cancer index were both 0.0. It was given a S.G.T. grade of 0.

The authors of this report have indicated that the S.G.T., based on the data in this report, is merely a crude screen to indicate potential L.T.T. tumorigens, not a test to be used to from definite positive or negative conclusions concerning tumorigenesis.

Interpretation of results:
study cannot be used for classification
Conclusions:
The indication is that some degree of corneal injury was induced by instillation of soybean oil, epoxidised. However, the 60 comparative materials listed in this report had scores in the range of 0-10 indicating the corneal injury induced by ESBO is slight or minimal.
Executive summary:

Carcinogenic and acute toxicity potential of teh test material was assayed.

Irritation

The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2.

Toxicity

A wide range of toxicity and irritation of epoxy monomers is documented in this report. No consistent correlations with structure are evident.

Carcinogenicity

The test was successfully completed. The test material was not considered to be tumorigenic to the mouse skin.

Sebaceous Gland Suppression

The mena number of sebaceous glands per square centimeter of skin of epoxide-dosed mice has been graded against that of the control mice. As the material was applied undiluted, it was compared to a distilled water control group. This substance was tested by both the sebaceous gland (S.G.T.) and the lifetime tests (L.T.T.). The L.T.T. was negative, the tumour and the cancer index were both 0.0. It was given a S.G.T. grade of 0.

The authors of this report have indicated that the S.G.T., based on the data in this report, is merely a crude screen to indicate potential L.T.T. tumorigens, not a test to be used to from definite positive or negative conclusions concerning tumorigenesis.

Sensitisation:

Sensitisation of guinea pigs was determined by a technique consisting of eight intracutaneous injections (three per week on alternate days) of 0.1 mL of the diluted epoxy materials. A three week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter.

It was concluded that the test material was not sensitising.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and  2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids

This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier.

Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.

Justification for classification or non-classification

Based on the data available, classification for skin and eye irritation is not required under the CLP Regulation.