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Diss Factsheets

Administrative data

Description of key information

For the submission substance, no data for testing irritating effects on the skin and the eyes are available. However adequate and reliable data for a structural analogue (i.e. C8C10TM, for read-across justification please see read-across report in section 13) revealed only very weak irritating effects on the skin of rabbits and no irritating effects on the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
assessment report
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:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal: #1 and #2
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable as no effect has been observed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Interpretation of results:
GHS criteria not met
Conclusions:
In this OECD guideline study 404, rabbits were exposed to undiluted 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters for 4 hours under semiocclusive conditions. Mean erythema scores from 24, 48 and 72 hour readings for each animal were in between 1 and 2. All animals were free of symptoms after 6 - 8 days. The test material showed only very weak irritating effects on the skin of rabbits.
Executive summary:
The study used as source investigated the acute skin irritating effects of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters. The test material 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 only a slightly irritating effect (primary dermal irritation index (PDII): 1.67) on the skin of male rabbits. Mean erythema scores from 24, 48 and 72 hour readings for each animal were in between 1 and 2. In two animals mean edema score was 0 and in one animal the mean edema score was 0.3. All animals were free of symptoms after 6 - 8 days.

Results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross-reference “assessment report”.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
assessment report
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no effect observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable since no effect observed
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable since no effect observed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no effect observed
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this guideline study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was not irritating to the eyes. 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.
Executive summary:

The study used as source investigated the acute irritating 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.

Results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross-reference “assessment report”.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data for testing irritating effects on the skin and the eyes are available for the submission substance. However adequate and reliable data for a structural anologue (i.e. C8C10TM, for read-across justification please see read-across report in section 13) are reported below.

To test the acute skin irritant effect, 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (C8C10TM) 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 only a slightly irritating effect (primary dermal irritation index (PDII): 1.67) on the skin of male rabbits. Mean erythema scores from 24, 48 and 72 hour readings for each animal were in between 1 and 2. In two animals mean edema score was 0 and in one animal the mean edema score was 0.3. All animals were free of symptoms after 6 - 8 days (Sasol_Mürmann, 1989, RL2).

To test the acute irritant effect of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (C8C10TM) 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 (Sasol_Mürmann, 1989, RL2).

No data for respiratory irritation are available for the submission substance or any of the structural analogues.

Justification for selection of skin irritation / corrosion endpoint:
Onyl study available. Adequate study performed with structural analogue and of high reliability (Klimisch score 2, according to guideline, no GLP)

Justification for selection of eye irritation endpoint:
Onyl study available. Adequate study performed with structural analogue and of high reliability (Klimisch score 2, according to guideline, no GLP)

Justification for classification or non-classification

According to the negative findings in reliable guideline studies performed with the structural analogue 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (C8C10TM) no classification for irritation of the skin nor for irritation of the eyes according to the criteria set in the Regulation (EC) No. 1272/2008 is proposed for the submission substance.

No data on respiratory irritation is available.