Registration Dossier
Registration Dossier
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EC number: 209-057-8 | CAS number: 554-00-7
Endpoint summary
Administrative data
Description of key information
Key, guinea pig maximisation test, read across to 3,4 dichloroaniline, positive
Supp, QSAR, Danish QSAR database, battery model, positive
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
please see attached justification statement - Reason / purpose for cross-reference:
- read-across source
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
5 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
none- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
5 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
4 animals with discrete or patchy erythema- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
5 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
1 animal with dicrete or patchy erythema- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
5 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
14 animals with discrete or patchy erythema- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
25 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
5 animals with discrete or patchy erythema- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
25 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- 17 animals with discrete or patchy erythema
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
25 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
7 animals with discrete or patchy erythema, 1 animal with moderate and confluent erythema- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
25 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
13 animals with discrete or patchy erythema, 6 animals with moderate and confluent erythema- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
50 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
7 animals with discrete or patchy erythema- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
50 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
11 animals with discrete or patchy erythema, 4 animals with moderate and confluent erythema and 3 animals with intense erythema and swelling- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
50 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
9 animals with discrete or patchy erythema- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
50 % 3,4-dichloroaniline in propylene glycol- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
15 animals with moderate to confluent erythema; 5 animals with discrete or patchy erythema- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- 3,4 -dichloroaniline was found to be sensitising in this guinea pig maximisation test.
- Executive summary:
3,4 -dichloroaniline was tested for skin sensitisation according to OECD Guideline 406 in a Magnusson and Kligman test in male guinea pigs. Although irritation was also evident in the control group after challenge or rechallenge with either 50, 25 or 5 % 3,4 -dichloroaniline in propylene glycol (w/w) the incidence and severity of irritation was always higher in the induced test group. Therefore 3,4 -dichloroaniline was concluded to be sensitising in this guinea pig maximisation test. Based on the read across approach, this result is also fully applicable to the registered substance 2,4 -dichloroaniline (for more information please refer to the Read Across Statement attached in Section 13).
Reference
During the range finding test for the challenge concentration acute dermal toxicity was observed after simultaneous exposure of each of five guinea pigs to 4 occlusive gauze patches treated with either 0.5 mL 6, 12, 25 or 50 % 3,4 -dichloroaniline in propylene glycol. Two animals were found dead after 24 h and the remaining three were euthanized for animal welfare reasons due to severe signs of toxicity.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Guinea pig maximisation Test - Read across to 3,4 -dichloroaniline
3,4 -dichloroaniline was tested for skin sensitisation according to OECD Guideline 406 in a Magnusson and Kligman test in male guinea pigs. Although irritation was also evident in the control group after challenge or rechallenge with either 50, 25 or 5 % 3,4 -dichloroaniline in propylene glycol (w/w) the incidence and severity of irritation was always higher in the induced test group. Therefore 3,4 -dichloroaniline was concluded to be sensitising in this guinea pig maximisation test. Based on the read across approach, this result is also fully applicable to the registered substance 2,4 -dichloroaniline (for more information please refer to the Read Across Statement attached in Section 13).
QSAR prediction
Skin sensitisation was predicted using the models Sci QSAR and CASE ULtra implemented in the Danish data base and the OECD QSAR toolbox v4.5. Positive indication of skin sensitisation was given by these QSAR predictions. The final result was drawn from the overall prediction of the battery model that contains 3 different models, for skin sensitisation implemented in the Danish QSAR database. For the Sci QSAR model and the CASE Ultra QSAR model the substance was predicted positive and the predictions fall in the applicability domain. The third model of the battery (Leadscope) could not make a prediction, as the substance was out of the applicability domain of the model.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, the registered substance is classified as skin sens 1 (H317) in accordance with Regulation (EC) No 1272/2008.
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