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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:
1977-12-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restriction because although it is an acceptable and well documented study report a GLP statement was not provided and details regarding the test material and animal husbandry was not provided.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Noakes and Sanderson (1969)
Principles of method if other than guideline:
Groups of rats were used for each of three dose levels. The test material was placed into shorn dorso-lumbar skin and bandaged. Rats were deprived of food but allowed water ad libitum during the 24 hour exposure period.
GLP compliance:
not specified
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): Internal Olefin 114 LP11
- Test substance: Alkenes, C11-15

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboratory (Tunstall), Breeding Unit
- Age at study initiation: Approximately 12 to 13 weeks
- Weight at study initiation: Not reported
- Fasting period before study: No
- Housing: Housed individually during the 24 hour exposure period. After exposure rats were housed 4 of one sex in each cage
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Type of coverage:
other: percutaneous
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorso-lumbar skin
- % coverage: Not reported
- Type of wrap if used: Impermeable dressing of aluminium foil and water proof plaster.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with tepid dilute detergent solution.
- Time after start of exposure: 24 hours

VEHICLE - The test substance was undiluted.
Duration of exposure:
24 hours
Doses:
1.0 mL/kg, 2.0 mL/kg and 4.0 mL/kg
No. of animals per sex per dose:
Four animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 9 days
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: No
- Other examinations performed: None

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
4 mL/kg bw
Remarks on result:
other: Equivalent to 3040 mg/kg
Sex:
male
Dose descriptor:
approximate LD50
Effect level:
2 - 4 mL/kg bw
Remarks on result:
other: Equivalent to 1520 to 3040 mg/kg
Mortality:
Three male rats died at the 4.0 ml/kg dose level. No deaths occurred at 1.0 or 2.0 ml/kg dose levels.
Clinical signs:
Rats showed no signs of toxic reactions.
Body weight:
Those animals that did die did not eat or drink and lost a considerable amount of body weight. Individual rat weight data was not provided.
Gross pathology:
Pathology data was provided.
Other findings:
- Organ weights: No data
- Histopathology: No data
- Potential target organs: No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Three males died at the 4.0 ml/kg dose level. This rats who died were noted to not eat or drink during the observation period, thus losing a considerable amount of body weight. No other deaths were reported. The acute percutaneous LD50 of Internal Olefin 114 LP11 in rats was greater than 4 ml/kg in females and between w and 4 ml/kg in males.
Executive summary:

In an acute percutaneous toxicity study, groups of young Wistar rats, 4 male and 4 female, were dermally exposed to undiluted Internal Olefin 114 LP11 for 24 hours at doses of 1, 2, and 4 mL/kg bw. Animals then were observed for 9 days.

Three males died at the 4.0 mL/kg dose level. This rats who died were noted to not eat or drink thus losing a considerable amount of body weight. No other deaths were reported. The acute percutaneous LD50 of Internal Olefin 114 LP11 in rats was greater than 4 mL/kg (i.e., 3040 mg/kg) in females and between 2 and 4 mL/kg (i.e., 1520 to 3040 mg/kg) in males.

 

This study received a Klimisch score of 2 and is classified as reliable with restriction because although it is an acceptable and well documented study report a GLP statement was not provided and details regarding the test material and animal husbandry was not provided.This study will influence the DNEL(s).