Alcohols, C11-14-iso-, C13-rich

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report equivalent or similar to OECD guideline 402: GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C11-14-iso-, C13-rich

EC Number:

271-235-6

EC Name:

Alcohols, C11-14-iso-, C13-rich

Cas Number:

68526-86-3

Molecular formula:

CnH2n+1OH (n = 11 to 14)

IUPAC Name:

Branched alcohols, C11-14, C13 rich

Details on test material:

- Name of test material (as cited in study report): Exxal 13
- Physical state: colorless liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: 11 – 13 weeks
- Weight at study initiation: male (233-268 g), female (187-205 g)
- Housing: individually
- Diet (e.g. ad libitum): Kliba 343, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- 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: backs
- % coverage: 10
- Type of wrap if used: occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tape water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml at 2000 mg/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

10

Control animals:

no

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,organ weights

Statistics:

No data analyzed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: All animals survived

Mortality:

All animals survived

Clinical signs:

other: Slight erythema observed within 24 hours of exposure. Resovled by 4 days post exposure.

Gross pathology:

No findings noted.

Other findings:

No findings noted.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 for isotridecanol is greater than 2000 mg/kg.

Executive summary:

In this study, 10 rats were exposure to 2000 mg/kg body weight of isotridecanol via an occluded dermal patch for 24 hours to assess acute toxicity.  Clinical observations were made at 1, 2, 3, 5, and 24 hours and daily thereafter for 14 days.  All animals survived the exposure. It is concluded that the LD50 is greater than 2000 mg/kg.