Carbamic acid ester

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Limited information available, although the conclusion the conclusion is considered to be valid

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1983

Report date:

1982

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The publication compares the following methods for the assessment of sensitization: Magnusson & Kligman (1969), Maguire (1973), and Maurer, Thomann, Weirich & Hess (1975), the Freund's Complete Adjuvant test (FCAT) of Klecak, Geleik & Frey (1977), the method of Dossou & Sicard (1984) and that of Brulos
et al. (1977).
As the Magnussen & Kligman test was adopted by the EC and the OECD, only the description of the method and the results for this test are included in the current summary.

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Published existing data

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

not specified

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source:Iffa-Crédo, L'Arbresle; Shamrock Farms, Henfield, Sussex, UK; Gwen Meur, Trégonneau
- Age at study initiation: not indicated
- Weight at study initiation: 300-500 g
- Housing: no data
- Diet: 50 g/day/animal Granulas Cobaye from Extra Labo, Longueville
- Water: softened and filtered (15/um) water) ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±1.5 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 12 times/ hour
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

1st induction: 0.5 mL at highest non-irritant concentration and as such
2nd induction: 0.5 mL at slightly irritant concentration
challenge: 0.5 mL at highest non-irritant concentration

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

1st induction: 0.5 mL at highest non-irritant concentration and as such
2nd induction: 0.5 mL at slightly irritant concentration
challenge: 0.5 mL at highest non-irritant concentration

No. of animals per dose:

20 females ( the substance was used as control)

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 hours
- Site: (2 × 4) cm2 area of median anterior dorsal surface
- Frequency of applications: inductions on day 1 and 8
- Concentrations:
1st induction: 0.5 mL at highest non-irritant concentration and as such
2nd induction: 0.5 mL at slightly irritant concentration

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 48 hours
- Site: (2 × 2) cm2 area of left flank
- Concentrations: 0.5 mL at highest non-irritant concentration
- Evaluation: 24 and 48 hours after challenge

OTHER: histopathological examination at 48 hours after challenge

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: both challenges

Hours after challenge:

24

Group:

test chemical

Dose level:

highest non-irritant concentration

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

other: Reading: other: both challenges. . Hours after challenge: 24.0. Group: test group. Dose level: highest non-irritant concentration. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Based on the information in the publication the substance did not induce sensitization

Executive summary:

In a maximisation test in guinea pigs (n=20), the substance did not induce sensitization. Several other protocols were tested in comparison, all leading to the same result. Therefore the substance is considered not sensitizing to the skin.