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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Reference substance name:
Alkenes, C11-15
IUPAC Name:
Alkenes, C11-15
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 or test system 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:
other: Rats showed no signs of toxic reactions.
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).