Carbendazim

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 18, 1996 - February 1, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study already available.

Test material

Test material information

Constituent 1

Reference substance name:

Carbendazim

EC Number:

234-232-0

EC Name:

Carbendazim

Cas Number:

10605-21-7

Molecular formula:

C9H9N3O2

IUPAC Name:

carbendazim

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

Four to five week old male .

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

No. of animals per dose:

For the main study 5 control animals and 10 test animals were used and housed in groups of 5 in the cages.

Details on study design:

Based on preliminary investigation, 5% w/v was selected for intradermal injection, 62.5% w/v for topical induction and 62.5 and 31.25% w/v for topical challenge.
For the main study the protocol of Magnusson & Kligman were used.
For intradermal induction, 3 pairs of injections were made into the clipped dorsal scapular region: Freund's complete adjuvant, carbendazim and a mixture of both. Six days later, the hair-freed region was treated with sodium lauryl sulphate in petrolatum to produce skin irritation. 24 hr later, a patch with carbendazim solution was applied to the skin for 48 hr.

Challenge controls:

For challenge, flanks were clipped free of hairs and patches with carbendazim solution were applied for 24 hr.
The challenge sites were evaluated 24, 48 and 72 hr after removal of the patches and the findings were described or scored according to the usual criteria.

Positive control substance(s):

yes

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: score after challenge

Hours after challenge:

72

Group:

test chemical

Dose level:

5% w/v for intradermal injection, 62.5% w/v for topical induction and 62.5 and 31.25% w/v for topical challenge.

No. with + reactions:

4

Total no. in group:

10

Any other information on results incl. tables

No signs of ill health or toxicity were reported. Body weights of animals increased.

Necrosis was seen at sites receiving Freund's complete adjuvant in test and control animals.

Slight irritation was seen in test animals and control animals receiving intradermal injections of carbendazim solution or solvent alone. Slight erythema was seen in test animals and control animals receiving dermal application of carbendazim sol. or solvent alone.

Dermal reactions were seen in four animals of the test group compared to none of the control animals. The other test animals showed no skin reactions.

Applicant's summary and conclusion

Conclusions:

Dermal induction and challenge induced in 4 out of 10 treated animal skin reactions indicative of sensitisation.
Based of the results of this magnusson & Kligman test, carbendazim needs classification and labelling as a skin sensitiser.