1-(2-Ethylbutyl)cyclohexanecarbonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

September 03, 2008 to September 18, 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 2004/10/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 Officiel de la République Française (see certificate of G.L.P. in appendix). TEST GUIDELINES: OECD no 423 (24 April 2002) Test method B.lter Council regulation No 440í2008

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

not specified

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks:

and OECD guideline 423

Any other information on results incl. tables

No mortality occurred during the study.

A decrease of the spontaneous activity (2/6) associated with an absence of Preyer's reflex (1/6), bradypnea (1/6), hypothermia (2/6), a decrease of muscle tone (1/6), the eyes partly closed (2/6), an absence of righting reflex (1/6) and a piloerection (2/6) was registered in the treated animals, 24 hours after the test item administration. The animals recovered a normal activity the 3rd day of the test. An absence of the body weight gain was noted in one treated animal, 48 hours after the test item administration. Then the body weight evolution of the animals remained normal.

The macroscopical examination of the animals at the end of the study revealed a white thickening layer on the forestomach (3/6).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item CAT NITRIL is higher than 2000 mg/kg body weight by
oral route in the rat.
In accordance with the OECD guideline no 423, the LD50 of the test item may be considered higher
than 5000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and
preparations in accordance with the E.E.C. Directives 67/548, 2001159 and 99/45, the test item CAT
NITRIL must not be classified. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not
be classified in category 4. No signal word and hazard statement are required.

Executive summary:

The test item CAT NITRIL was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline No 423 dated December 17th, 2001 and the test method B.lter of the Council regulation No 440/2008. No mortality occurred during the study. A decrease of the spontaneous activity (2/6) associated with an absence of Preyer's reflex (1/6), bradypnea (1/6), hypothermia (2/6), a decrease of muscle tone (1/6), the eyes partly closed (2/6), an absence of righting reflex (1/6) and a piloerection (2/6) was registered in the treated animals, 24 hours after the test item administration. The animals recovered a normal activity the 3rd day of the test. An absence of the body weight gain was noted in one treated animal, 48 hours after the test item administration. Then the body weight evolution of the animals remained normal. The macroscopical examination of the animals at the end of the study revealed a white thickening layer on the forestomach (3/6). In conclusion, the LD5o of the test item CAT NITRIL is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline no 423, the LD50 of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item CAT NITRIL must not be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal word and hazard statement are required.