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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: See Remark
Remarks:
The data provided in conjunction with that of report DuPont-19883-1234 provide a weight of evidence for the hazard endpoint that is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
test was conducted before LLNA method was adopted

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 96%
Specific details on test material used for the study:
Purite: 100%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: contol animals average weight - 508 g; test animals average weight - 518 g
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS: not reported

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: See Remark
Remarks:
Dimethyl phthalate (DMP)
Concentration / amount:
8% and 80% in DMP
Day(s)/duration:
4 weeks
Challenge
Route:
other: epicutaneous
Vehicle:
other: see Remark
Remarks:
Dimethyl phthalate (DMP)
Concentration / amount:
8% and 80% in DMP
Day(s)/duration:
24 and 48 hrs
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS: No sensitisation was observed at 10, 21, 42, or 83% (w/v) when tested in 3 guinea pigs per concentration.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: 4 weeks
- Test groups: 1, 80% and an 8% suspension of the test material in the primary irritation test on same animal
- Control group: yes, no treatment
- Site: sacral intradermal injection
- Frequency of applications: 1 each week beginning 2 days after the test for primary irritation
- Duration: 4 weeks
- Concentrations: 0.1 ml of a 1.0% suspension in DMP,

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 days
- Exposure period: 24 hours and 48 hours
- Test groups: 1, 80% and an 8% suspension of the test material on same animal
- Control group: yes, At the same time 10 unexposed guinea pigs (controls) of the same age received identical topical applications.
- Site: shaved, intact shoulder skin.
- Concentrations: 0.05 ml of an 80% and an 8% suspension of test material in DMP
- Evaluation (hr after challenge): 24 hours and 48 hours
Challenge controls:
At the same time 10 unexposed guinea pigs (controls) of the same age received identical topical applications (0.05 ml of an 80% and an 8% suspension of test material in DMP).

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
all
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
all
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

The test substance caused no irritation on shaved intact skin of 10 guinea pigs at 24 or 48 hours in both the primary irritation test and in the sensitization challenge. None of the test guinea pigs showed a sensitization response.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
not sensitizing
Conclusions:
Not sensitising

This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
Executive summary:

The primary irritation test was conducted on 10 unexposed guinea pigs by applying and lightly rubbing in 0.05 mL of an 80% and an 8% suspension of the test material in DMP on shaved, intact shoulder skin. The induction phase began 2 days after the primary irritation test and continued for 4 weeks, one injection each week. After a 13-day rest period, the test guinea pigs were challenged for sensitization by applying and lightly rubbing in 0.05 mL of an 80% and an 8% suspension of test material in DMP on shaved, intact shoulder skin. The test substance caused no irritation on shaved intact skin of 10 guinea pigs at 24 or 48 hours. None of the test guinea pigs showed a sensitization response.