1-Cyclohexene-1-carboxaldehyde, 2-chloro-3-(hydroxymethylene)-, (3E)-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF, Japanese Test Guidelines

Test guideline 5

Qualifier:

according to guideline

Guideline:

other: method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig"

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Adequate existing data that allow a conclusion on the sensitizing potential of the substance were available

Test material

Test material information

Constituent 1

Reference substance name:

(3E)-2-chloro-3-(hydroxymethylidene)cyclohex-1-ene-1-carbaldehyde

EC Number:

801-656-8

Cas Number:

1416808-92-8

Molecular formula:

C8H9ClO2

IUPAC Name:

(3E)-2-chloro-3-(hydroxymethylidene)cyclohex-1-ene-1-carbaldehyde

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

propylene glycol

Induction 2

Concentration / amount:

preliminary irritation study (intradermal): 50%, 20%, 10%, 5%, 2%, 1%, 0.5% and 0.2%
preliminary irritaion study (epidermal): 50%, 20%, 10%, 5%, 2%
main irritation study (induction): 0.5% (intradermal) and 5% (epidermal)
main irritation study (challenge): 1% and 5%

Challenge

Challenge 1

Route:

epicutaneous, semiocclusive

Vehicle:

propylene glycol

Challenge 2

Concentration / amount:

preliminary irritation study (intradermal): 50%, 20%, 10%, 5%, 2%, 1%, 0.5% and 0.2%
preliminary irritaion study (epidermal): 50%, 20%, 10%, 5%, 2%
main irritation study (induction): 0.5% (intradermal) and 5% (epidermal)
main irritation study (challenge): 1% and 5%

No. of animals per dose:

10

Positive control substance(s):

yes

Remarks:

alpha-hexylcinnamic aldehyde, tech.85%

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

other: induction readings

Group:

negative control

Dose level:

0.5% and 5%

Total no. in group:

5

Clinical observations:

max. erythema grade: 3; max. signs of necrosis: 8 mm in diameter. The skin reactions were considered to be signs of non-specific irritation.

Remarks on result:

other: see Remark

Remarks:

Reading: other: induction readings. Group: negative control. Dose level: 0.5% and 5%. Total no. in groups: 5.0. Clinical observations: max. erythema grade: 3; max. signs of necrosis: 8 mm in diameter. The skin reactions were considered to be signs of non-specific irritation..

Results 2

Reading:

other: induction readings

Group:

test chemical

Dose level:

0.5% and 5%

Total no. in group:

10

Clinical observations:

max. erythema grade: 3, max. signs of necrosis: 8 mm in diameter

Remarks on result:

other: Reading: other: induction readings. Group: test group. Dose level: 0.5% and 5%. Total no. in groups: 10.0. Clinical observations: max. erythema grade: 3, max. signs of necrosis: 8 mm in diameter.

Results 3

Reading:

other: challenge readings

Group:

negative control

Dose level:

1% and 5%

Total no. in group:

5

Clinical observations:

grade 1 scaliness (at dose level 5%); no response (at dose level 1%). The skin reactions were considered to be signs of non-specific irritation.

Remarks on result:

other: see Remark

Remarks:

Reading: other: challenge readings. Group: negative control. Dose level: 1% and 5%. Total no. in groups: 5.0. Clinical observations: grade 1 scaliness (at dose level 5%); no response (at dose level 1%). The skin reactions were considered to be signs of non-specific irritation..

Results 4

Reading:

other: challenge readings

Group:

test chemical

Dose level:

1% and 5%

Total no. in group:

10

Clinical observations:

grades up to 3, scabs and scaliness (both at 1% and 5%)

Remarks on result:

other: Reading: other: challenge readings. Group: test group. Dose level: 1% and 5%. Total no. in groups: 10.0. Clinical observations: grades up to 3, scabs and scaliness (both at 1% and 5%).

Any other information on results incl. tables

Yellow staining was observed at the test substance treated skin sites, 24 and 48 hours after challenge. This staining did not hamper the scoring of the skin reactions.

No mortality occurred and non symptoms of systemic toxicity were observed in the animals of the main study.

Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

v171629 should be labelled as R43.