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Toxicological information

Skin sensitisation

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Administrative data

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.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diphenylsulfon (DPS)
- Substance type: organic
- Physical state: solid, white powder
- Analytical purity: > 99%
- Purity test date: 15/05/2001
- Lot/batch No.: 1712SA
- Expiration date of the lot/batch: 15/05/2002
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature in the dark
- Other: bulk density: 0.7-0.8
stability in vehicle (corn oil): not indicated

In vivo test system

Test animals

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:

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.