Alcohols, C9-11-branched and linear

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Method: other: in house protocol

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C9-11-branched and linear

EC Number:

288-284-4

EC Name:

Alcohols, C9-11-branched and linear

Cas Number:

85711-26-8

Molecular formula:

C9H20O, C10H22O and C11H24O

IUPAC Name:

Alcohols, C9-11-branched and linear

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Camm Research Institute, Wayne, New Jersy, USA
- Age at study initiation: Not reported
- Weight at study initiation: average weight 3.10 kg
- Fasting period before study:
- Housing: individual cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 weeks



ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 20.2
- Humidity (%): average 46.3
- 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: back/trunk
- % coverage: 4X4 inches
- Type of wrap if used: Gauze plus impervious wrap (Saran) and elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remaining material removed using a moist  towel.
- Time after start of exposure: 24h

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

Duration of exposure:

24 hours on intact and abraded skin

Doses:

2 ml/kg

No. of animals per sex per dose:

- Group size: 4M+4F
- Controls: 4M+4F

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical signs were made at  1,2,4,6 and 24 hours after application and then twice daily through out  the 14 day observation period. Body weights were measured on days -1, 0,  7 and 14. 
- Necropsy of survivors performed: yes
- Other examinations performed:  Each exposure site was scored (Draize)  for degree of irritation immediately on removal of the dressings and  prior to termination on day 14. 

Statistics:

calculation of mean and standard  deviation. Determination of the significance of bodyweight changes  compared to controls was made using an independent T-test.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 660 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the exposure and 14 day observation  period. The dermal LD50 is therefore >2 ml/kg, this is equivalent to 1660  mg/kg using a density of 0.83 for conversion.

Clinical signs:

other: There were no treament related signs of toxicity.  There was minimal skin irritation at the 24 hour period  for both intact and abraded skin. Mean erythema and oedema scores for  intact skin were 1.9 and 1.1 respectivley compared to 0.2 and 0.1 in the  co

Gross pathology:

The presence of white flaky material at the  application site was the only remarkable finding.

Other findings:

POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity study for for Alcohols, C9-11 branched and linear, conducted according to a protocol similar to OECD Test Guideline 402 and in compliance with GLP, reports an LD50 value of >1660 mg/kg bw.