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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:
supporting study
Study period:
9/16/85-1/24/86
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to the corresponding protocol and it is GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Protocol C 4A
Deviations:
no
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
-Physical state: white solid
- Storage: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Labaratory Supply Company
- Weight at study initiation: 300-400 g
- Acclimation period: 4 days

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: Closed patch on clipped areas of intact skin
Vehicle:
other: mineral oil, acetone and 80/20 ETOH/H2O
Concentration / amount:
7.5%, 2.5%, 0.75% w/v, 0.5%, 0.25% w/v, 7.5%, 2.5%, 0.75% w/v
Challengeopen allclose all
Route:
other: For patch placement
Vehicle:
other: mineral oil, acetone and 80/20 ETOH/H2O
Concentration / amount:
7.5%, 2.5%, 0.75% w/v, 0.5%, 0.25% w/v, 7.5%, 2.5%, 0.75% w/v
No. of animals per dose:
20 test animals, 10 control animals for rechallenge

Results and discussion

Any other information on results incl. tables

see executive summary

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
There were six responders (score >1) in a group of twenty guinea pigs previosly exposed to 2.5% of B0823-02 when challenged with 0.25% of B0823-02. There were no responders ion the control group. The test animals were rechallenged with 0.25% of B0823-02 and 1.0% of B0889-01. Testing with B0823-02 resulted in one responders in the test group and no responders in the control group. Testing with B0889-01 resulted in two responders in the test group and no responders in the control group. There was one responder (score >1) in a group of twenty guinea pigs previously exposed to 0.75% of B0823-02 when challenged with 0.25% of B0823-02. There were no responders in the control group. The test animals were rechallenged with 0.25% of B0823-02 and 1.0% of B0889-01. There were no responders from either test article. There were no responders in the control group. There were no respoders (score >1) in a group of twenty guinea pigs previously to 0.25% of B0823-02 when challenged with 0.25% of B0823-02. There were no responders in the control group. The test animals were rechallenged with 0.25% of B0823-02 and 1.0% of B0889-01. There were no responders from either test article. There were no responders in the control group.
Executive summary:

A no-effect level of induction was established at 0.75% for B0823-02 in mineral oil following exposure to 0.25, 0.75 or 2.5% and a primary challenge of 0.25%. Six of 20 animals induced at 2.5% responded at challenge. Animals were rechallenged with B0823-02 (0.25%) and B0889-01 (1% in mineral oil). Some animals induced at 2.5% responded to both rechallenge substances (1/20 and 2/20, respectively). All other animals tested gave negative responses.