[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 May - 17 June 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No information on purity was given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

No information on purity was given.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dimethylbutyl (E)-but-2-enoate

Molecular formula:

C10H18O2

IUPAC Name:

1,3-dimethylbutyl (E)-but-2-enoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 10 - 12 weeks
- Weight at study initiation: 262 - 285 g (males), 237 - 264 g (females)
- Housing: individually during the 24 h exposure period and subsequently up to 5 animals of the same sex per cage in polypropylene cages on sawdust
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 2.5
- Humidity (%): 45 - 66
- Air changes (per hr): approx. 10
- 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: skin of the dorsal, lateral and ventral regions (6 cm x 12 cm)
- % coverage: 10%
- Type of wrap if used: The treated skin was covered with a surgical gauze patch (7 cm x 4 cm) which was held in place with a strip of elastic adhesive bandage (7.5 cm wide and 25-30 cm long) wrapped around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin and surrounding hair were sponged thoroughly with warm water, rinsed and dried using absorbant paper.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amounts applied: 0.06, 0.46, 2.29 and 5.71 mL/kg bw (range-finding study); 5.71 mL/kg bw (main study)
- Constant concentration used: yes

Duration of exposure:

24 h

Doses:

Range-finding study: 50, 400, 2000 and 5000 mg/kg bw
Main study: 5000 mg/kg bw

No. of animals per sex per dose:

Range-finding study: 2
Main study: 5

Control animals:

not required

Details on study design:

Range-finding study:
- Duration of observation period following administration: 7 days
- Frequency of observations: Animals were observed 30 min and 1 and 4 h after administration and subsequently once daily for 7 days.

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min and 1, 2, 3, 4 and 5 h after administration and subsequently at least once daily for 14 days. Individual body weights were determined on Days 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

No deaths or clinical signs of toxicity were noted up to the highest concentration tested throughout the 7-day observation period. The dose level selected for the main study was therefore 5000 mg/kg bw.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No signs of systemic toxicity were noted until the end of the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute dermal toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.

Executive summary:

An acute dermal toxicity study was performed with male and female rats according to OECD 402 under GLP conditions. After a range-finding study with the dose levels 50, 400, 2000 and 5000 mg/kg bw, a main study with 5000 mg/kg bw was performed. No mortality occurred during the study period of the range-finding study and the main study.

In this acute dermal toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.