1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters

Endpoint summary

Description of key information

- skin irritation / corrosion (OECD 404): not irritating

- eye irritation (OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Feb - 11 Mar 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted in May 1981)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: The Broekman Institute, Someren, NL
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 2.574 - 2.901 kg
- Housing: individually in metal cages with perflorated floors
- Diet: 100 g/day, (LK-01, pellet diameter 4 mm, Hope Farms, Woerden)
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: shame exposed site at the left flank of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): unchanged liquid test substance

Duration of treatment / exposure:

4 hours

Observation period:

14 days
Reading time points: 55 min, 24, 48 and 72 h and 7 and 14 days

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on the right flank
- Type of wrap if used: gauze patch mounted on permeable tape (Micropore, 3M, St. Paul, USA) and wrapped in flexible bandage (Coban, 3M, St. Paul, USA)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with dry tissue and subsequently a tissue moistened with tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

The skin of all three animals showed well-defined erythema and very slight to slight edema. The redness had decreased to very slight within 24 h in animals #2 and #3 and on day 3 in animal #1. The irritation was reversible within 7 days in two animals and within 14 days in one animal.

Other effects:

Signs of systemic intoxication were not observed in any of the rabbits throughout the observation period.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 - 19 Jul 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of details on test substance

GLP compliance:

yes (incl. QA statement)

Remarks:

The department of health and social security of the government of the United Kingdom

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.55 - 2.75 kg
- Housing: individually in suspended metal cages
- Diet: Spillers Rabbit Diet, Dalgety Agriculture Ltd., Bristol, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 53-61
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): unchanged liquid test substance

Duration of treatment / exposure:

single eye instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize scoring system


TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

No adverse corneal or iridial effects were noted in the treated eyes during the study. Minimal conjunctivial redness was noted in two treated eyes 1 h after treatment. Residual test substance was noted around the treated eyes of all animals 1 h after treatment. All eyes appeared normal within 24 h.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The skin irritation potential of 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters (CAS 94279-36-4) has been investigated in two studies in rabbits.

One study investigating the skin irritation potential of 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters (84% pure) was performed in New Zealand White rabbits according to OECD guideline 404 under GLP conditions (Croda Europe Ltd., 1987). The undiluted test substance (0.5 mL) was applied for 4 h to the shaved skin of the right flank of 3 female rabbits under semiocclusive conditions. The untreated site of the animals served as control. After patch removal residues of the test substance were washed off. The scoring of skin reactions (erythema and edema) was performed 55 min, 24, 48 and 72 h as well as 7 and 14 days after removal of the dressing. The skin of all three animals showed well-defined erythema (mean scores over 24, 48 and 72 h per animal: 1.67, 1.0, and 1.0, respectively) and very slight to slight edema (mean scores over 24, 48 and 72 h per animal: 1.0, 1.0, and 1.33, respectively). The redness had decreased to very slight within 24 h in 2 animals and on day 3 in one animal. All effects were fully reversible within 7 days in 2 animals and within 14 days in one animal.

An additional study was performed according to OECD 404 with 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters (no data on purity) under GLP conditions (Croda Europe Ltd., 1991). 0.5 mL of the test substance was applied to the clipped skin of 3 male New Zealand White rabbits for 4 h. After removing the semiocclusive dressing the test site was gently washed. The skin reactions were scored after 1, 5, 24, 48, and 72 hours and 5, 7, 9, and 11 days after treatment. Very slight erythema (score = 1) was noted in one animal 1 h after and in all animals 5 and 24 h after patch removal. This effect lasted until the 48 h scoring in only one animal. No edema was observed in any animal. Thus, all effects were fully reversible within 72 h at the latest and the test substance was considered non-irritating.

In summary, 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters is not irritating to the skin.

Eye irritation:

CAS 94279-36-4

The eye irritation potential of 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters was investigated in a study according to OECD guideline 405 under GLP conditions (Croda Europe Ltd., 1991). 0.1 mL of the undiluted test material (no data on purity) was placed into the conjunctival sac of the right eye of 3 male New Zealand White rabbits. The other eye remained untreated and served as control. The eyes were examined and scored 24, 48, and 72 h after application. No effects on iris, cornea or conjunctivae were observed in the animals at any reading time point. No further local or systemic toxic effects were observed. Therefore, the observation period was reduced to 72 h. The mean cornea, iris, conjunctivae and chemosis scores after 24, 48, and 72 h were 0.0 for all 3 animals, respectively. Based on the results of this study, 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters is not eye irritating.

Justification for classification or non-classification

The available data on skin irritation/corrosion and eye irritation do not meet the classification criteria according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.