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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate protocol and in compliance with GLP.

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:
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C9-11 alcohols Cas# 66455-17-2 (Neodol 91) 84% linear monobranched at the 2 position

- Physical state: a clear, non-viscous liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals 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:
other: undiluted
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: clinical signs, body weight, organ weights, histopathology, other:  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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 660 mg/kg bw
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:
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  controls. For abraded skin erythema and oedema scores were 2 and 1  respectively with control values of 0.6 and 0.1. No irritation was  evident at 14 days.
Body weight:
 Bodyweights in treated animals were comparable to those of controls.
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:
other: data not sufficient for classification decision
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
The rabbit dermal LD50 (24 occlusive exposure) for Neodol 91 is >1660 mg/kg. Other than irritation at the application site, reversible within the 14 day observation period, there were no other signs of toxicity.