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Toxicological information

Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
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.