Alkenes, C11-14

Acute Toxicity: dermal

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

Test material information

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 levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

4 mL/kg bw

Remarks on result:

other: Equivalent to 3040 mg/kg

Effect levels 2

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).