Registration Dossier

Administrative data

Description of key information

No skin or eye irritation potential was observed in any of these studies.
A study on acute dermal toxicity was available for 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters.
Studies on skin and eye irritation were available for the following Read Across substance (CAS No.): 68442-70-6.

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Justification for grouping of substances and read-across

There are no data available on the in vivo skin irritation potential of 1,2-Benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3). In order to fulfil the standard information requirements set out in Annex VIII, 8.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

Overview of skin Irritation / corrosion

CAS

Chemical name

Skin irritation

90193-76-3 (a)

1,2 Benzenedicarboxylic acid, di-C16-C18-alkyl esters

WoE:

RA: 68442-70-6

Not irritating

68442-70-6 (b)

1,2-Benzenedicarboxylic acid, mixed cetyl and stearyl esters

Experimental result:
not irritating

(a) The substance subject to registration is indicated in bold font.

(b) Reference (read-across) substances are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for 1,2-Benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

Discussion

Skin irritation

1,2-Benzenedicarboxylic acid, mixed cetyl and stearyl esters (CAS No. 68442-70-6) was screened for dermal irritation in rabbits using a patch test method in vivo (Potokar, 1981). Rabbits were exposed for 4 hours to a 50% solution of the test substance. No dermal irritation was observed. No further details were given in this short study summary.

The acute dermal toxicity (limit test) of 1,2 Benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS No. 90193-76-3) was investigated in male and female Wistar rats in a GLP study according to OECD guideline 402. Chromodacryorrhoea on the snout was noted in the majority of animals and piloerection and/or hunched posture were also noted for several animals. The animals had recovered from the symptoms between Days 2 and 3. No mortalities and no abnormalities at necropsy were observed in animals dosed with 2000 mg/kg body weight. The LD50 was found to be greater than 2000 mg/kg bw (Stitzinger, 2010).

In accordance with Column 2 of REACH Annex VII-VIII, in vitro skin irritation and corrosion studies (required in Section 8.1 of REACH Annex VII) or an in vivo skin irritation study (required in Section 8.1.1 of REACH Annex VIII) need not to be conducted as an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight). Therefore, no further testing is needed.

Based on the results, 1,2 benzenedicarboxylic acid, di-C16-C18-alkyl esters is not irritating to the skin.

 

 

Eye irritation

Justification for grouping of substances and read-across

There are no data available on the in vivo eye irritation potential of 1,2-Benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3). In order to fulfil the standard information requirements set out in Annex VIII, 8.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

Overview of eye Irritation / corrosion

CAS

Chemical name

Eye irritation

90193-76-3 (a)

1,2 Benzenedicarboxylic acid, di-C16-C18-alkyl esters

WoE:

RA: 68442-70-6

QSAR: not irritating

68442-70-6(b)

1,2-Benzenedicarboxylic acid, mixed cetyl and stearyl esters

Experimental result:
not irritating

 

(a) The substance subject to registration is indicated in bold font.

(b) Reference (read-across) substances are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for 1,2-Benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

Discussion

Eye irritation

1,2-Benzenedicarboxylic acid, mixed cetyl and stearyl esters (CAS No. 68442-70-6) was tested for its eye irritation potential (Potokar, 1973). The test material (50% in olive oil) was tested in New Zealand White rabbits. Eye reactions were recorded immediately, 2 h, 6 h and 24 h after instillation. The eyes of all treated animals were unchanged after treatment. No eye irritation was observed.

In a second study, 1,2-Benzenedicarboxylic acid, mixed cetyl and stearyl esters (CAS No. 68442-70-6) was tested in a screening test for its eye irritation potential (Potokar, 1981). Single instillation of the test substance at concentrations of 5% and 10% into the eyes of each two rabbits did not result in any ocular reactions in these animals.

In addition, determination with the OECD QSAR Toolbox v3.1 whether inclusion rules (based on structural alerts) and exclusion rules (based on PC parameters) for eye irritation/corrosion revealed that 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters is not considered to be corrosive or irritating, and thus does not need to be classified.

Based on a weight of evidence approach , 1,2 benzenedicarboxylic acid, di-C16-C18-alkyl esters is not eye irritating.

 

Conclusions for irritation / corrosion

No data on skin and eye irritation is available for 1,2-Benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3).

However, the results of the skin irritation studies of the structurally related substances 1,2-Benzenedicarboxylic acid, mixed cetyl and stearyl esters (CAS No. 68442-70-6) indicate that 1,2-Benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3) will not cause skin irritation. The results of the eye irritation studies using the same structural analogues for read-across (Potokar, 1973; Potokar, 1981) indicate that 1,2-Benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS 90193-76-3) will not cause eye irritation. Regarding the PC based rules for log Kow, water solubility and molecular weight, 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters is not considered to be corrosive or irritating, and thus does not need to be classified.

Justification for classification or non-classification

Based on a substance specific study and read-across following an analogue approach, the available data on the skin and eye irritation potential do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

There are no data available on respiratory irritation.