1-(2-Ethylbutyl)cyclohexanecarbonitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

between 08 September 2008 and 26 September 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The entire work was devised and performed in compliance with the principles of the Good Laboratory Practice (G.L.P.), as defined in the directive 2004/1 O/EC, the O. E. C. D. ruling relative to the mutual acceptance of data in the evaluation of chemical substances (C(8l) 30 final) Appendix 2 - May 12th, 1981; C (97) 186, November 26th, 1997), and in the French decree no 2006-1523 dated December 04th, 2006 of the Journal Oficiel de la République Française (see certijìcate of G.L.P. in appendk). TEST GUIDELINES: OECD no 404 (24 April 2002) Test method B.4 Council regulation No 440/2008

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

CAT Nitril

IUPAC Name:

CAT Nitril

Details on test material:

Sponsor's identification: CAT NITRIL
Date received : 29 July 2008
Container : glass flask (n=l)
Form : liquid
Quantity : 130.99 g (container + contents)
Colour : brown
Storage : room temperature
Expiry date: 27 December 2008
Production date: April 2007

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were appreciated 1 hour and then 24,48 and 72 hours after removal of the patch.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

ca. 2

Reversibility:

fully reversible within: day 6

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

3

Reversibility:

fully reversible within: between 5 to 6 days

Other effects:

24 hours after the patch removal, a well defined erythema associated with a moderate oedema was
noted on the treated area. The oedematous reactions were totally reversible between D5 and D6, and
the erythematous reactions were totally reversible at D6.
On the cutaneous structure, dryness was noted on the treated area, from D2 in two animals and from
D4 in a third animal. The skins recovered a normal aspect between D8 and D13.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The results obtained, in these experimental conditions, enable to conclude that the test item
CAT NITRIL according to the scales of interpretation retained:
- is irritant to skin (Psi = 5.0) according to the classification established in the Journal Oflciel de la
République Française dated February 21st, 1982,
- and, must be classified R38 “irritant to skin”, according to the criteria for classification,
packaging and labelling of dangerous substances and preparations in compliance with the E.E.C.
Directives 67/548, 2001/59 and 99/45. The item must be characterised by the symbol “Xi” and the
warning label “Irritant”.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be
classified in category 2 “Irritant”. The signal word “Warning” and hazard statement H315 “Causes
skin irritation” are required.

Executive summary:

The test item CAT NITRIL was applied, as supplied, at the dose of 0.5 mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established from the O.E.C.D. guideline no 404 dated April 24th, 2002 and the test method B.4 of Council regulation No 440/2008. 24 hours after the patch removal, a well defined erythema associated with a moderate oedema was noted on the treated area. The oedematous reactions were totally reversible between D5 and D6, and the erythematous reactions were totally reversible at D6. On the cutaneous structure, dryness was noted on the treated area, from D2 in two animals and from D4 in a third animal. The skins recovered a normal aspect between D8 and D 13. The results obtained, under these experimental conditions, enable to conclude that the test item CAT NITRIL must be classified R38 “irritant to skin”, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. The item must be characterised by the symbol “Xi“ and the warning label “Irritant”. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 2 “Irritant”. The signal word “Warning” and hazard statement H315 “Causes skin irritation” are required.