Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-06-10 to 1985-06-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

On 5 occasions the relative humidity was beyond the 70 % recommended by the Guideline for 4-22 h. Following cage-side observations revealed no abnormalities.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1983

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile

EC Number:

919-489-5

Molecular formula:

C13H23N

IUPAC Name:

Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adult animals
- Weight at study initiation: males: 282-370 g, females: 210-233 g
- Fasting period before study: none
- Housing: individually in Macrolon cages
- Diet: ad libitum standard laboratory diet (Hope Farms, Woerden, The Netherlands)
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 45-90
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lateral area
- % coverage: ca. 10 % of total body surface
- Type of wrap if used: aliminum foil, fixed with flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing: the skin was gently dabbed with wet tissues in order to remove remaining test substance
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

one limit dose of 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Statistical analysis was not carried out as no deaths occured.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured at the limit dose of 2000 mg/kg bw.

Clinical signs:

Slight irritation was observed accompanied by spots with severe irritation in 4 animals during the first few days.

Body weight:

Group mean body weights were slightly reduced for the males and unchanged in females on day 7, but returned to normal by the end of the study.

Gross pathology:

No treatment related gross abnormalities were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test substance was determined to be greater than 2000 mg/kg bw.

Executive summary:

A limit study on acute dermal toxicity was conducted according to OECD 402 in rats. 5 male and 5 female Wistar rats were dermally treated with one dose of 2000 mg/kg bw of the test substance. The substance was applied under occlusion and the patches remained on the skin sites for 24 hours. The skin was gently dabbed with wet tissues in order to remove remaining test substance after removal. During the 14 -day observation period no deaths occurred and no signs of systemic toxicity were noted. Irritated skin sites found on all animals returned to normal by the end of the observation period. No test item related macroscopic findings were reported at autopsy. Based on these results, the dermal LD50 value was determined to be greater than 2000 mg/kg bw.