Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Justification for type of information:
The DPS dossier containsold in vivo studies, which are not allowed today. Therefore a justification needs to be added in the end point data summary. The new legal requirements (21 June 2016) require an in vitro skin sensitisation study.However the previous data requirements were met with an in vivo study during the dossier compilation for the 100-1000 T/Y tonnage band. Therefore there is no need to repeat the study using the alternatiuve test method.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
The DPS dossier containsold in vivo studies, which are not allowed today. Therefore a justification needs to be added in the end point data summary. The new legal requirements (21 June 2016) require an in vitro skin sensitisation study.However the previous data requirements were met with an in vivo study during the dossier compilation for the 100-1000 T/Y tonnage band. Therefore there is no need to repeat the study using the alternatiuve test method.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River deutschland, kisslegg, Germany
- Age at study initiation: approximately 4 weeks old
- Weight at study initiation: individual body weights < 500 grams
- Housing: group housing of 5 animals per labelled metal cage (57 cm * 41 cm * 23 cm height) with wiremesh floors.
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid (1000 mg/kg); (Charles River Breeding and Maintenance Diet for guinea pigs, Altromin, Lage, Germany). Certificates of analysis were examined and retained in the NOTOX archives. Hay (B.M.I., Helmond, The Netherlands) was provided twice a week.
- Water (e.g. ad libitum): Free access to tap water. Certificates of analysis were examined and retained in the NOTOX archives.
- Acclimation period: 4 days before the start of the treatment under laboratory conditions, instead of at least 5 days before the start of the study. However, this slight deviation from the protocol was considered not to have affected the study integrity.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +- 3°c
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs artificial fluorescent light


IN-LIFE DATES: From: To:
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% test substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.

Induction phase: Skin effects were not recorded after the last (3rd) induction exposure.

Challenge phase: No skin reactions were evident after the challenge exposure in the experimental and control animals.

Toxicity/Mortality: no mortality occured and no symptomes of systemic toxicity were observed in the animals of the main study.

Body Weights: Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
There was no evidence that diphenylsulfon (DPS) had caused skin hypersensitivity in the guinea pig, since no responces were observed in the experimental animals in the challenge phase. This result indicates a sensitation rate of 0%.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), diphenylsulfon (DPS) does not hve to be classified and has no obligatory labelling requirement for sensitation by skin contact.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A key study for dermal sensitization was conducted with diphenyl sulphone according to OECD 406 Boehler method in guinea pigs (Notox, 2002). No skin reactions were observed after 3 epidermal induction phases for 6 h (day 1, 8 and 15) with 0.5 ml of a 50% test substance concentration, and after challenge for 6h (day 28) with 0.1 ml of a 50% test substance concentration under occlusion. No mortality occurred and no symptoms of systemic toxicity were observed. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. There was no evidence that diphenyl sulphone had caused skin hypersensitivity in a key guinea pig Buehler test, since no responses were observed in the experimental animals in the challenge phase.


Migrated from Short description of key information:
Diphenyl sulphone was tested for skin hypersensitivity in a guinea pig Buehler test and was negative for sensitisation in the challenge phase.

Justification for selection of skin sensitisation endpoint:
Key study

Justification for classification or non-classification

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC) and CLP regulation (EC No. 1272/2008 of 16 December 2008) , diphenyl sulphone does not have to be classified and has no obligatory labelling requirement for sensitation by skin contact.