cis-2-tert-butylcyclohexyl acetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Limitations: amount of substance applied and time between challenge and scoring are unknown

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

The protocol looks similar to the Buehler test

Principles of method if other than guideline:

The guinea pigs were treated twice daily for 21 days on the shaved flank for the irritation portion. Following a 5 day rest, a virgin site was shaved on the neck and the test article applied for 5 consecutive days.

GLP compliance:

no

Type of study:

Buehler test

Justification for non-LLNA method:

Currently no LLNA study is available for assessment. The Buehler test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Test material information

Constituent 1

Reference substance name:

cis-2-tert-butylcyclohexyl acetate

EC Number:

243-718-1

EC Name:

cis-2-tert-butylcyclohexyl acetate

Cas Number:

20298-69-5

Molecular formula:

C12H22O2

IUPAC Name:

2-tert-butylcyclohexyl acetate

Test material form:

liquid

Details on test material:

Test material used is consistent with the substance identity as described in section 1.2 of IUCLID - company composition for the quality described under the common name Verdox.

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright white

Sex:

not specified

Details on test animals and environmental conditions:

- Weight at study initiation: ca. 300-500 g

Study design: in vivo (non-LLNA)

Induction

Route:

other: epicutaneous (not specified)

Vehicle:

unchanged (no vehicle)

Concentration / amount:

Concentrated form

Challenge

Route:

other: epicutaneous (not specified)

Vehicle:

unchanged (no vehicle)

Concentration / amount:

Concentrated form

No. of animals per dose:

20 (sex unknown)

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 42
- Exposure period: 21 days
- Test group: 20 animals
- Control group: none
- Site: shaved flank
- Frequency of applications: twice daily
- Duration: not specified
- Concentrations: concentrated form

B. CHALLENGE EXPOSURE
- No. of exposures: 5
- Day(s) of challenge: starting from 15 days post-exposure daily
- Exposure period: 5 days
- Test group: 20 animals
- Control group: none
- Site: shaved neck
- Concentrations: concentrated form
- Evaluation (hr after challenge): no data

Challenge controls:

No data

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

No skin reactions were observed.

Results 2

Group:

negative control

Remarks on result:

not measured/tested

Results 3

Group:

positive control

Remarks on result:

not measured/tested

Any other information on results incl. tables

The dose level is assumed to be 100 % but the % is limitedly documented in the report.

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitising

Remarks:

in accordance with EU CLP (1272/2008 and its updates)

Conclusions:

The substance gave negative results in a Buehler study with guinea pigs (OECD TG 406).

Executive summary:

Skin sensitizing properties of Verdox were tested in the study with 20 Pirbright white guinea pigs. The study preceeded OECD guidelines and GLP but is similar to OECD TG 406. The study is a limitedly reported: amount of substance applied and time between challenge and scoring are unknown). Positive controls were not reported. The guinea pigs were treated twice daily for 21 days on the shaved flank for the irritation portion. Following a 5 day rest, a virgin site was shaved on the neck and the test article applied for 5 consecutive days. The length of the observation period was not specified. No skin reactions were noted in any of the animals.