1,2-diacetoxybut-3-ene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Remarks:

CD(SD)BR/VAF Plus

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Kingston (Stone Ridge, NY)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Males 6 to 7 weeks and females 7 to 8 weeks
- Weight at study initiation: Males 162 to 191g and females 161 to 170g
- Fasting period before study: None
- Housing: Singly housed in suspended stainless steel wire mesh cages.
- Diet (e.g. ad libitum): Certified rodent diet freely available
- Water (e.g. ad libitum): Water available freely
- Acclimation period: 5 days ahead of study initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 54 to 60%
- Air changes (per hr): Not detailed
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Not detailed (applied to dorsal surface)
- % coverage: Not detailed
- Type of wrap if used: Occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes (running water)
- Time after start of exposure: After 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw applied directly

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At least once daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight

Statistics:

Not applicable to study design

Preliminary study:

Not conducted

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 mortality was observed

Clinical signs:

other: No toxicologically significant clinical signs were observed

Gross pathology:

No toxicologically significiant findings were noted at necropsy

Interpretation of results:

GHS criteria not met

Conclusions:

A reliable guideline study indicates that the test material is unlikely to cause dermal toxicity or skin irritation after exposure to the substance, with an LD50 value > 2000 mg/kg bw.