Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine

Endpoint summary

Description of key information

Skin corrosion/irritation in vivo

The test material was not found to be corrosive or irritant to skin (OPPTS 870.2500).

 

Eye damage/irritation in vivo

The test material was not found to cause serious eye damage or eye irritation (equivalent or similar to 16 CFR 1500.42).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Reference 2

Endpoint:

skin irritation: 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

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 October 2000 - 7 November 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: ca. 3 months Animals born on 2000-07-15
- Weight at study initiation: 2.0 - 2.7 kg
- Housing: Suspended wire cages, 1 rabbit/cage
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Quarantine period of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled environment, but no information provided
- Humidity (%): controlled environment, but no information provided
- Air changes (per hr): controlled environment, but no air change information provided
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 2000-10-24 To: 2000-11-07

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL/rabbit (2.5 x 2.5 cm area)

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 rabbits ( 2 males, 1 female)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No data
- Type of wrap if used: 4 ply surgical gauze patch secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With distilled water on removal of wrapping.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Erythema was barely perceptible at 60 minutes following patch removal, well defined at 24 and 48 hours, well defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Oedema was barely perceptible at 60 minutes following patch removal, well defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well defined on day 7 and absent by day 14.

Other effects:

There were no abnormal systemic signs noted during the observation period.
Bodyweight changes were normal.

Table 1: Dermal observations, body weights and systemic observation

Rabbit Ear-tag	F5983	F5990	F5955
Sex	M	F	M
Pre-test body weight (kg)	2.7	2.0	2.7
72 h weight (kg)	2.7	2.0	2.8
Day 7 weight (kg)	2.7	2.1	2.8
Terminal body weight (kg)	2.8	2.2	2.8
Time after patch removal	Erythema and Eschar Formation
60 mins	1	1	1
24 hours	2	2	2
48 hours	2	2b*	2
72 hours	3	2p	2p
7 days	1f*	4f*	0f
14 days	0*	0*	0
	Oedema
60 mins	1	1	1
24 hours	2	2	3
48 hours	1	2	2
72 hours	1	2	2
7 days	1	2	0
14 days	0	0	0
	Systemic Observations
60 mins	A	A	A
24 hours	A	A	A
48 hours	A	A	A
72 hours	A	A	A
7 days	A	A	A
14 days	A	A	A

A = normal, b = brown areas, f = flaking skin, p = pale areas, *= reclipped

Interpretation of results:

not classified

Conclusions:

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

Executive summary:

Test Guidance

In accordance with EPA guideline OPPTS 870.2500

Method and Material

Three New Zealand White rabbits were dosed dermally with 0.5 mL of the test material to one intact site per rabbit. Semiocclusive wrapping was applied for 4 hours after which the wrapping was removed and the test site washed. Dermal reactions were scored using the Draize method at 60 minutes, 24, 48 and 72 hours and on days 7 and 14 of the observation period. The skin was also evaluated for ulceration, necrosis or evidence of skin destruction.

Results

Erythema was barely perceptible at 60 minutes following patch removal, well-defined at 24 and 48 hours, well-defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Edema was barely perceptible at 60 minutes following patch removal, well-defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well-defined on day 7 and absent by day 14. Bodyweights were recorded pre-test and termination. There were no abnormal systemic signs noted during the observation period and body weight changes were normal.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

Reference 4

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

14 September 1982 - 20 October 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

GLP-like (QA signature), guideline study with 24 hour exposure and termination at 72 hours without evidence of reversibility

Qualifier:

equivalent or similar to guideline

Guideline:

other: 16 CFR 1500.41 Federal Hazardous Substances Act

Principles of method if other than guideline:

Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24h. Treated areas were examined at 24h after treatment and scoring using the Draize method was done at 72h after treatment.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 rabbits

Details on study design:

TEST SITE
- Area of exposure: back
- % coverage: no data available
- Type of wrap if used: Gauze patch covered with an impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not applicable

SCORING SYSTEM: Draize method

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

1.8

Max. score:

4

Reversibility:

no data

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

1.9

Max. score:

4

Reversibility:

no data

Remarks on result:

other: abraded skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

1.8

Max. score:

4

Reversibility:

no data

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

1.9

Max. score:

4

Reversibility:

no data

Remarks on result:

other: abraded skin

Other effects:

No data

Interpretation of results:

not classified

Conclusions:

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

Executive summary:

Test Guidance

Skin irritation study performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.

Method and Material

Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.

Results

Very slight to well-defined erythema and edema formation was observed at the intact and abraded sites of all animals at 24 hours. At 72 hours well-defined to moderate/severe erythema was observed at the intact and abraded sites of all animals and very slight to well-defined edema was observed at intact sites and well-defined to moderate/severe edema was observed at abraded sites of all animals. There was no evidence of reversibility over the limited timeframe of the study.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 September 1982 - 20 October 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP-like study (QA signature)

Qualifier:

equivalent or similar to guideline

Guideline:

other: 16 CFR 1500.42 Federal Hazardous Substances Act

GLP compliance:

yes

Remarks:

GLP-like study (QA signature)

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: No data available.
- Age at study initiation: No data available.
- Housing: Stainless steel with elevated wire mesh flooring; 1 rabbit per cage
- Water: Tap water ad libitum
- Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 ± 2°F (22°C)
- Humidity (%): 45 ± 5%
- Air changes: controlled environment, but no air change information provided.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1982-09- 13 To: 1982 -09-20

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Eyes were not rinsed throughout study

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

Six rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not appliacable

SCORING SYSTEM: Draize method

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

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: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Interpretation of results:

not classified

Conclusions:

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.

Executive summary:

Test Guidance

Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act,

Method and Material

0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.

Results

No irritation was observed in any animal at any observation period.

Conclusion

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin corrosion/irritation in vivo

 

Key study

The key study was performed in accordance with EPA guideline OPPTS 870.2500. Three New Zealand White rabbits were dosed dermally with 0.5 mL of the test material to one intact site per rabbit. Semiocclusive wrapping was applied for 4 hours after which the wrapping was removed and the test site washed. Dermal reactions were scored using the Draize method at 60 minutes, 24, 48 and 72 hours and on days 7 and 14 of the observation period. The skin was also evaluated for ulceration, necrosis or evidence of skin destruction.

Erythema was barely perceptible at 60 minutes following patch removal, well-defined at 24 and 48 hours, well-defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Edema was barely perceptible at 60 minutes following patch removal, well-defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well-defined on day 7 and absent by day 14. Bodyweights were recorded pre-test and termination. There were no abnormal systemic signs noted during the observation period and body weight changes were normal.

 

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

Supporting study

The supporting study was performed using a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations. Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.

 

Very slight to well-defined erythema and edema formation was observed at the intact and abraded sites of all animals at 24 hours. At 72 hours well-defined to moderate/severe erythema was observed at the intact and abraded sites of all animals and very slight to well-defined edema was observed at intact sites and well-defined to moderate/severe edema was observed at abraded sites of all animals. There was no evidence of reversibility over the limited timeframe of the study.

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

Eye damage/irritation in vivo

The key study was performed using a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act, 0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale. No irritation was observed in any animal at any observation period.

Justification for classification or non-classification

Skin corrosion/ irritation in vivo

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

 

Eye damage/irritation in vivo

No ocular effects were observed in any animal at any observation period. In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.