Amines, C20-22-alkyldimethyl

Skin sensitisation

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

Test material information

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)

Induction

Induction 1

Route:

other: Closed patch on clipped areas of intact skin

Vehicle:

other: mineral oil, acetone and 80/20 ETOH/H2O

Induction 2

Concentration / amount:

7.5%, 2.5%, 0.75% w/v, 0.5%, 0.25% w/v, 7.5%, 2.5%, 0.75% w/v

Challenge

Challenge 1

Route:

other: For patch placement

Vehicle:

other: mineral oil, acetone and 80/20 ETOH/H2O

Challenge 2

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.