Reaction mass of methyl 2-[[(E)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate and methyl 2-[[(Z)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 April 2000 - 24 April 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

An assessment of acute toxicity is required to fulfil REACH Annex VII information requirements. The acute dermal toxicity study was conducted according to OECD TG 402, GLP and is considered reliable without restriction (Klimisch 1).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 2-[[(Z)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate

Molecular formula:

C17H21NO2

IUPAC Name:

Methyl 2-[[(Z)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate

Constituent 2

Reference substance name:

Methyl 2-[[(E)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate

Molecular formula:

C17H21NO2

IUPAC Name:

Methyl 2-[[(E)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species, Strain: Sprague-Dawley CD (Crl:CD (SD) IGS BR)
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: Males - 200-218 g. Females - 201-221 g
- Housing: Suspended polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse Expanded Diet No.1, ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back and flanks
- % coverage: 10
- Type of wrap if used: Surgical gauze semi-occluded with a piece of self-adhensive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Wiped with cotton wool moistened with arachis oil BP
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration: 2000 mg/kg bodyweight

Duration of exposure:

24 hour exposure, with a 14-day observation period

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2 and 4 hours after dosing, then once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, clinical signs, dermal reactions, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No deaths

Clinical signs:

other: No clinical signs of toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No signs of dermal Irritation were noted during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item was determined to be > 2000 mg/kg bodyweight.

Executive summary:

The acute dermal toxicity of the test item was determined in a limit test with male and female Sprague-Dawley rat. The backs and flanks of the animals were shorn and the test material was applied unchanged at a dosage of 2000 mg/kg bodyweight. The treatment sites were semi-occluded and rats were exposed to the test item for 24 hours. Mortality, clinical signs of toxicity, dermal reactions and body weight were observed for 14 days following treatment. There were no mortalities observed, therefore the LD50 was determined to be > 2000 mg/kg bodyweight. No signs of dermal irritation, clinical signs of toxicity or abnormal bodyweight changes were observed throughout the study duration. This study is considered to be reliable without restrictions (Klimisch 1) as it was GLP-compliant and was performed according to OECD guideline 402.