Registration Dossier

Diss Factsheets

Administrative data

Description of key information

1,2,4 -benzenetricarboxylic acid, mixed decyl and octyl triesters showed either no or slight irritant to skin and eye


 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
29 May 2013 to 01 June 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in accordance with OECD and EU Guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.49 to 2.59 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: Free access to food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon., UK)
- Water: Free access to mains drinking water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23 degrees C.
- Humidity (%): The humidity was set to achieve 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to 12 hours continous light (06:00 to 18:00) and 12 hours darkness.

IN-LIFE DATES: From: 29 March 2013 To: 1 April 2013
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL

The pH of the test item was determined prior to the commencement of the study and found to be as follows:
Undiluted as supplied: Immediately: pH 7.9
90% v/v aqueous preparation of the test item: immediately: pH 7.7, after 10 minutes: pH 7.8
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: No information.
- % coverage: No information.
- Type of wrap if used: 2.5 cm x 2.5 cm cotton gauze patch. Secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: The corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale:

Erythema and Eschar Formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4

Edema Formation:
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well-defined by definite raising) : 2
Moderate edema (raised approximately 1 millimeter): 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure): 4

Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
Individual body weights were recorded on Day O (the day of dosing) and at the end of the observation period.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: Total of erythema and edema scores at 24 and 72 hours for all 3 animals divided by 6
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
8
Reversibility:
other: not applicable
Irritant / corrosive response data:
Very slight erythema was noted at one treated skin site one hour after patch removal. No evidence of skin irritation was noted at two treated skin sites.
Other effects:
All animals showed expected gain in body weight.

Individual skin reactions:

 

 

Skin Reaction

 

Observation Time (following patch removal)

 

Individual Scores -Rabbit Number and Sex

 

 

Total

 

73212 Male

 

73213 Male

 

73214 Male

 

 

 

Erythema/Eschar Formation

Immediately

0

0

0

( 0)

1 Hour

1

0

0

(1)

24 Hours

0

0

0

0

48 Hours

0

0

0

( 0)

72 Hours

0

0

0

0

 

 

 

 

Edema Formation

Immediately

0

0

0

( 0)

1 Hour

0

0

0

( 0)

24 Hours

0

0

0

0

48 Hours

0

0

0

( 0)

72 Hours

0

0

0

0

Sum of 24 and 72-Hour Readings (S)                             0

Primary Irritation Index (S/6)                                      0/6 =0.0

Classification                                                         NON-IRRITANT

(   ) = Total values not used for calculation of primary irritation index

Individual Body Weights and Body Weight Change:

 

Rabbit Number and Sex

Individual Body Weight (kg)

 Body Weight Change (kg)

Day 0

Day 3

73212

Male

 

2.49

 

2.53

 

0.04

73213

Male

 

2.59

 

2.67

 

0.08

73214

Male

 

2.50

 

2.55

 

0.05
Interpretation of results:
GHS criteria not met
Conclusions:
The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize Classification Scheme.No corrosive effects were noted.
Executive summary:

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

A single 4 -hour semi-occluded application of the test item to intact skin of three rabbits produced an isolated incident of very slight erythema at one treated skin site one hour after patch removal. No evidence of skin irritation was noted at two treated skin sites.

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-04-18 to 1989-05-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10 x 10 cm of shaved skin of the dorsal and lateral parts of the trunk of the animals, application of the test substance on a skin area of approx. 6 cm²
- % coverage: not mentioned
- Type of wrap if used: semi-occlusion with a gauze patch (2.5 cm x 2.5 cm). The patch was secured in position by an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD guideline 404
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.67
Max. score:
8
Reversibility:
fully reversible within: 6 to 8 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: after 6 days Scaling which disappears after 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.56
- Edema: 0.11
All animals showed slight to well-defined erythema, and two animals after 1 resp. 24 hours slight edema. Allanimals were free of symptoms after 6 - 8 days.
Other effects:
scurf formation in one animal

Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

1/2/1

 0/1/0

24 h

 1/2/2

 0/0/1

48 h

 1/2/2

 0/0/0

72 h

 1/2/1

 0/0/0

Average 24h, 48h, 72h

 1.56

 0.11

Reversibility*)

 c.

 c.

Average time (unit) for reversion

 8 days

 8 days

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
GHS criteria not met
Conclusions:
All animals showed slight to well-defined erythema, and two animals after 1 resp. 24 hours slight edema. All animals were free of symptoms after 6 - 8 days.
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters showed a slightly irritant effect on the skin of the test animals with a primary dermal irritation index (PDII) of 1.67/8. The average scores were as follows: Erythema: 1.56, Edema: 0.11
Executive summary:

To test the acute skin irritant effect, 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was applied to shaven dorsal skin of rabbits. The product was administered undiluted, and the time of exposure in the patch test was 4 hours. The test was carried out in accordance with OECD guideline 404 (12 May 1981).


The test substance showed a slightly irritating effect (primary dermal irritation index (PDII): 1.67) on the skin of male rabbits. Mean Irritation scores derived from the respective erythema and edema scores for the 24, 48 and 72 hours observations were 1.56 (erythema) and 0.11 (edema).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
17 June 2013 to 27 June 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in accordance with OECD and EU Guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.13 to 2.64 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: Free access to food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon. UK
- Water: Free access to mains drinking water.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23 degrees C.
- Humidity (%): The humidity was set to achieve 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to 12 hours continous light (06:00 to 18:00) and 12 hours darkness.

IN-LIFE DATES: From: 17 June 2013 To: 27 June 2013
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1mL
- Concentration: 100%

The pH of the test item was determined prior to the commencement of the study and found to be as follows:
Undiluted as supplied: Immediately: pH 7.9
90% v/v aqueous preparation of the test item: immediately: pH 7.7, after 10 minutes: pH 7.8
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: N/A

SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation (Draize, J.H, 1977).

TOOL USED TO ASSESS SCORE: light source from a standard opthalmoscope.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: This is corneal opacity score. Multiplied by area of cornea involved and by 5 to give total score ( max: 80)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: This is corneal opacity score. Multiplied by area of cornea involved and by 5 to give total score ( max: 80)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: This is corneal opacity score. Multiplied by area of cornea involved and by 5 to give total score ( max: 80)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 amd 72 hours (mean)
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Score is multiplied by 5 to give total score (max: 10)
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Score is multiplied by 5 to give total score (max: 10)
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Score is multiplied by 5 to give total score (max: 10)
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours (mean)
Score:
1.33
Max. score:
10
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Includes chemosis, redness and discharge scores. Score is multiplied by 2 to give total score (max: 20)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours (mean)
Score:
1
Max. score:
10
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Includes chemosis, redness and discharge scores. Score is multiplied by 2 to give total score (max: 20)
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
1.67
Max. score:
10
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Includes chemosis, redness and discharge scores. Score is multiplied by 2 to give total score (max: 20)
Irritation parameter:
other: conjunctival redness
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours (mean)
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: conjunctival redness
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: conjunctival redness
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No corneal effects were noted during the study.
Iridial inflammation was noted in one treated eye at the 24 hour observation.
Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation noted in two treated eyes one hour after treatment. Minimal conjunctival irritation was noted in all treated eyes at the 24 hour and 48 hour observations.
All treated eyes appeared normal at the 72 hour observation.
Other effects:
Slight body weight loss was noted in one animal and two animals showed expected gain in body weight during the study.

Individual Scores and Individual Total Scores for Ocular Irritation:

 Rabbit Number andSex

73261Male

73283Male

73284Male

IPR =0

IPR =0

IPR =0

Time After Treatment

1

Hour

24

Hours

48

Hours

72

Hours

1

Hour

24

Hours

48

Hours

72

Hours

1

Hour

24

Hours

48

Hours

72

Hours

CORNEA

 

 

 

 

 

 

 

 

 

 

 

 

E = Degree of Opacity

0

0

0

0

0

0

0

0

0

0

0

0

F = Area of Cornea Involved

0

0

0

0

0

0

0

0

0

0

0

0

Score (E x F) x 5

0

0

0

0

0

0

0

0

0

0

0

0

IRIS

 

 

 

 

 

 

 

 

 

 

 

 

D

0

1

0

0

0

0

0

0

0

0

0

0

Score (D x5)

0

5

0

0

0

0

0

0

0

0

0

0

CONJUNCTIVAE

 

 

 

 

 

 

 

 

 

 

 

 

A =Redness

2

2

1

0

1

1

1

0

1

1

1

0

B =Chemosis

1

1

0

0

1

0

0

0

1

0

0

0

C =Discharge

1

0

0

0

1

1

0

0

1

0

0

0

Score (A + B + C) x2

8

6

2

0

6

4

2

0

6

2

2

0

TotalScore

8

11

2

0

6

4

2

0

6

2

2

0

Individual Total Scores and Group Mean Scores for Ocular Irritation:

Rabbit Number and Sex

Individual Total Scores At:

1 Hour

24 Hours

48 Hours

72 Hours

73261 Male

8

11

2

0

73283 Male

6

4

2

0

73284 Male

6

2

2

0

Group Total

20

17

6

0

Group Mean Score

6.7

5.7

2.0

0.0

Individual Body Weights and Body Weight Change:

Rabbit Number and Sex

Individual Body Weight (kg)

Body Weight Change (kg)

Day 0

Day 3

 

73261 Male

 

2.64

 

2.63

 

-0.01

 

73283 Male

 

2.13

 

2.15

 

0.02

 

73284 Male

 

2.44

 

2.54

 

0.10
Interpretation of results:
GHS criteria not met
Conclusions:
The test item produced a maximum group mean score of 6.7 (at 1 hour observation) and was classified as mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. In accordance with the CLP regulation, the substance is not classified for eye irritation.
Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit.

 

Results

A single application of the test item to the non-irrigated eye of three rabbits produced iridial inflammation and minimal to moderate conjunctival irritation. All treated eyes appeared normal at the 72-Hour observation.

 

Conclusion

The test item produced a maximum group mean score of 6.7 (at 1 hour observation) and was classified as mild irritant to the rabbit eye according to a modified Kay and Calandra classification system. In accordance with the CLP regulation, the substance is not classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-05-09 to 1989-05-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 h and 7 days after treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 72 hours


SCORING SYSTEM: according to Draize (Appraisals of the Saftey of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas 1959, page 51)


TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 72 hours after administration
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.0
- Conjuntivae (Chemosis): 0.0

Other effects:
DESCRIPTION OF LESIONS: 1 hour after application circumcorneal injections in all animals and mild discharge in one animal

Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

 0/0/0

 1/1/1

 0/0/0

24 h

 0/0/0

 0/0/0

 0/0/0

 0/0/0

48 h

 0/0/0

 0/0/0

 0/0/0

 0/0/0

72 h

 0/0/0

 0/0/0

 0/0/0

 0/0/0

Average 24h, 48h, 72h

 0

 0

 0

 0

Area effected

 -

 -

 -

 -

Maximum average score (including area affected, max 110)

 0

 0

 2.67

 0

Reversibility*)

 -

 -

 c.

 -

Average time (unit) for reversion

 -

 -

 24 hours

 -

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
GHS criteria not met
Conclusions:
The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:
Cornea opacity: 0.0
Iris lesion: 0.0
Redness of conjuntiva: 0.0
Oedema of conjunctiva: 0.0
Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa.
Executive summary:

To test the acute irritant effect of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters on the eyes and mucosa, 0.1 cm³ of the liquid test substance was administered into the conjunctival sac of one eye of each of three male rabbits. After exposure for 72 hours, the eyes were washed out with warm physiological saline. The test was carried out according to OECD guideline 405 (12 May 1982).

The test showed that administration of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters caused no irritation reactions at cornea and iris. At the conjunctivae 1 hour after application circumcorneal injections in all animals and mild discharge in one animal were observed, after 24 hours all animals were free of symptoms.

The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:

Cornea opacity: 0.0

Iris lesion: 0.0

Redness of conjuntiva: 0.0

Oedema of conjunctiva: 0.0

Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa.

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

Additional information

Acute skin and eye irritation studies with 1,2,4 -Benzenetricarboxylic acid, decyl octyl ester have been conducted in rabbits.


In the key study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was slightly irritating to the skin, the effects in the skin were fully reversible within 8 days. In a supporting study no skin irritation was found.


In the key study to test the acute irritant effect of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters on the eyes and mucosa, 0.1 cm³ of the liquid test substance was administered into the conjunctival sac of one eye of each of three male rabbits. After exposure for 72 hours, the eyes were washed out with warm physiological saline. The test was carried out according to OECD guideline 405 (12 May 1982).


The test showed that administration of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters caused no irritation reactions at cornea and iris. At the conjunctivae 1 hour after application circumcorneal injections in all animals and mild discharge in one animal were observed, after 24 hours all animals were free of symptoms.


The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:


Cornea opacity: 0.0


Iris lesion: 0.0


Redness of conjuntiva: 0.0


Oedema of conjunctiva: 0.0


Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa.


In a supporting study the test item produced a maximum group mean score of 6.7 (at 1 hour observation) was slightly irritant.


Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

The results of the skin and eye irritating studies show that 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters does not warrant classification according to Regulation (EC) No 1272/2008.