Bis(C12-C13)alkyl-2-hydroxybutandioate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March - April 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): COSMACOL EMI
- Substance type: pure active substance
- Physical state: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Morini - S. Polo d'Enza (RE), Italy
- Age at study initiation: no data
- Weight at study initiation: 170 - 230 g
- Fasting period before study: not mentioned
- Housing: in groups of 5 per sex per cage (polycarbonate, dimensions 425x266x180 mm)
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29-MAR-1993 To: 12-APR-1993

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg

Duration of exposure:

no data

Doses:

2000 m/kg bw at a volume of 2 mL/kg.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: daily in the working week (5 out of 7 days)
Clinical symptoms (including evaluation of body functions, tegumentary apparatus, mucosae conditions, respiratory activity, somatomotor activity and sensorium conditions): daily in the working week (5 out of 7 days)
Body weight: before the experiment, at day 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2 mL/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2 mL/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels: None

Body weight:

Body weight gain was normal during the study

Gross pathology:

No pathological symptoms were observed, nothing abnormal was found.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 dermal in the rat was greater than 2000 mg/kg bw.

Executive summary:

The test of acute dermal toxicity was performed on a group of ten rats (5 male and 3 female) according to EEC Directive 92/69. The test material Bis(C12-C13)alkyl-2-hydroxybutandioate, was administered at a dose of 2000 mg/kg bw by dermal application. During the study no case of mortality occurred. No clinical symptoms were observed, the body weight gain was normal for the used species. At necropsy the animals showed no pathological symptoms and nothing abnormal was found.

The LD50 was greater than 2000 mg/kg bw and Bis(C12-C13)alkyl-2-hydroxybutandioate was found to be non-toxic under experimental conditions.