(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde

Endpoint summary

Description of key information

The acute oral toxicity for (R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde was determined to be > 2000 mg/kg bw according to a study performed in agreement with OECD Guideline 401.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26th May 1998 to 9th June 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: A GLP compliant study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source :IFFA-CREDO (69210 - L'Arbresle, France)
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 172-204 g (males); 172-191 g (females)
- Fasting period before study: overnight
- Diet (e.g. ad libitum): complete pelleted rat maintenance diet UAR A04-10 (91360- Epinay Sur Orge, France)
- Housing: polypropylene cages (310 x 465 x 190)
- Acclimation period: at least 5 days

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

2000 mg/kg

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: a clinical observation was carried out at least once a day in order to evaluate the general appearance, behaviour and vegetative functions of the animals. An individual clinical observation was performed one hour after treatment. The continuous observations during the following five hours were each renewed the following day. Bodyweights were taken just prior to administration of the test substance and again on days 4, 8 and 15.
- Necropsy of survivors performed: at termination of the study, the rats were sacrificed and all abnormalities recorded.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Just after the treatment, and during the first six hours following administration of the test substance, a slight piloerection was noticed in all animals with a decrease in motor activity and in muscle tone (staggering gait) appearing 1 hour after treatme

Gross pathology:

Gross necroscopy of animals 14 days after treatment did not show any visible organic or tissular lesions which may imply a possible systemic toxicity of the test substance.

Table 1: Individual animal bodyweights

Animal number	D1	D4	D8	D15	D15 -D1
Male
9285	185.0	201.6	264.0	331.8	146.8
9286	172.2	193.3	251.8	311.0	138.8
9287	180.6	202.0	264.8	324.7	144.1
9288	203.8	207.9	262.9	332.3	128.5
9289	178.4	192.3	255.4	307.7	129.3
Mean	184.0	199.4	259.8	321.5	137.5
SD	12.0	6.5	5.8	11.6	8.4
Female
9290	182.2	184.5	215.7	233.2	51.0
9291	187.6	199.5	238.3	264.8	77.2
9292	190.8	203.2	227.4	259.3	68.5
9293	180.8	189.4	235.9	258.6	77.8
9294	172.0	189.9	221.6	238.4	66.4
Mean	182.7	193.3	227.8	250.9	68.2
SD	7.2	7.8	9.5	14.1	10.9

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the acute oral toxicity of the test substance was determined to be LD50 >2000 mg/kg bw.

Executive summary:

In a GLP compliant acute oral toxicity study conducted in line with standardised guideline OECD 401, the acute oral toxicity of the test substance was determined. Under the conditions of the test, the LD₅₀ of the test substance in rats was determined to be >2000 mg/kg bw and so the substance is considered to be unclassified for acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is GLP complaint and has Klimisch score of 1.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Substance is an intermediate and only available data need to be submitted.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral

The key study was performed in line with GLP and a standardised guideline at a single dose of 2000 mg/kg. No mortality occurred during the study and so the LD50 for the test substance was set as >2000 mg/kg bw. The study was selected as the key study on the basis that it was performed in line with GLP and a standardised guideline.

Justification for classification or non-classification

Oral

According to Regulation (EC) No 1272/2008, the studies available suggest that the test substance is considered to be unclassified for acute oral toxicity.