Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it appears to adhere to OECD 402 guidelines. There is no statement on GLP compliance because the study was conducted prior to the implementation of GLP.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it appears to adhere to OECD 402 guidelines. There is no statement on GLP compliance because the study was conducted prior to the implementation of GLP.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
Male albino rabbits weighing between 2.3 to 3.0 kilograms were kept under observation for 7 days prior to study initiation. Other animal specifics or environmental conditions were not reported in the study.
Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: Trunk area
- Type of wrap if used: Surgical gauze covered with impervious plastic film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, washing procedure not specified
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Maximum justifiable volume administered was 16 ml/kg animal body weight
- Constant volume or concentration used: Yes

Duration of exposure:
24 hours
Doses:
10 g/kg
No. of animals per sex per dose:
4 male rabbits
Control animals:
other: Control animals seems to have been used per results table in the study report, but specifics are missing.
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 1, 2, 3, 4, 7 and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, histopathology
Statistics:
Statistical analysis, if performed, is not provided in the report.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Remarks on result:
other: Test chemical applied to abraded skin had no impact on study results
Mortality:
No mortality reported.
Clinical signs:
other: Taut, dry and scaly skin with no re-growth of hair in the clipped areas accompanied by loss of hair in areas that became wet with the test chemical during administration.
Gross pathology:
Autopsy results revealed not gross pathological findings.

The study author reported that none of the treated rabbits died. Treated animals exhibited taut, dry and scaly skin with no re-growth of hair in the clipped areas accompanied by loss of hair in areas that became wet with the test chemical during administration. Autopsy at study termination showed no gross signs of damage in the internal organs. However, slight signs of pneumonia were observed in both the treated and control groups. Based on the study result, the author concluded that the acute dermal LD50 for the C12-C16 blend was greater than 10,000 mg/kg.

Interpretation of results:
other: Not classified
Remarks:
Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU
Conclusions:
Dermal LD50 for C12-16 alpha olefin blend is >10,000 mg/kg.
Executive summary:

In an acute dermal penetration study, groups of 4 male albino rabbits were kept under observation for 7 days prior to study initiation. Prior to dosing, the animals were clipped free of hair over the entire trunk area. One half of the animals were further prepared for the study by making longitudinal epidermal abrasions that were sufficiently deep enough to penetrate the stratum corneum, but not deep enough to penetrate the derma and cause bleeding. All animals were wrapped with surgical gauze and covered with an impervious plastic film. Each animal was then dosed with 10 g/kg of C12 -16 Alpha Olefin blend introduced under the plastic film via a syringe and catheter. Following dosing, the animals were immobilised in stocks for 24 hours after which the plastic film, gauze and excess test material were removed. The animals were returned to their cages for a 14 day post treatment observation period. The test conditions generally complied with the guideline requirements for this study type. The study author reported that none of the treated rabbits died. Treated animals exhibited taut, dry and scaly skin with no re-growth of hair in the clipped areas accompanied by loss of hair that became wet with the test chemical during administration. Autopsy at study termination showed no gross signs of damage in the internal organs. However, slight signs of pneumonia were observed in both the treated and control groups. Based on the study result, the author concluded that the acute dermal LD50for the C12-C16 blend was greater than 10,000 mg/kg.

This study received a Klimisch rating of “reliable with restrictions” because it appears to adhere to OECD 402 guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
C12-16 alpha olefin
IUPAC Name:
C12-16 alpha olefin
Constituent 2
Reference substance name:
Alkenes, C12-14 α-
EC Number:
292-463-2
EC Name:
Alkenes, C12-14 α-
Cas Number:
90622-61-0
Molecular formula:
C12H24 and C14H28
IUPAC Name:
Alkenes C12-14 α-
Details on test material:
- Name of test material (as cited in study report): C12-16 alpha olefin blend
- Substance type: C12-16 alpha olefins
- Analytical purity: 98.5%

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
Male albino rabbits weighing between 2.3 to 3.0 kilograms were kept under observation for 7 days prior to study initiation. Other animal specifics or environmental conditions were not reported in the study.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: Trunk area
- Type of wrap if used: Surgical gauze covered with impervious plastic film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, washing procedure not specified
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Maximum justifiable volume administered was 16 ml/kg animal body weight
- Constant volume or concentration used: Yes

Duration of exposure:
24 hours
Doses:
10 g/kg
No. of animals per sex per dose:
4 male rabbits
Control animals:
other: Control animals seems to have been used per results table in the study report, but specifics are missing.
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 1, 2, 3, 4, 7 and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, histopathology
Statistics:
Statistical analysis, if performed, is not provided in the report.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Remarks on result:
other: Test chemical applied to abraded skin had no impact on study results
Mortality:
No mortality reported.
Clinical signs:
other: Taut, dry and scaly skin with no re-growth of hair in the clipped areas accompanied by loss of hair in areas that became wet with the test chemical during administration.
Gross pathology:
Autopsy results revealed not gross pathological findings.

Any other information on results incl. tables

The study author reported that none of the treated rabbits died. Treated animals exhibited taut, dry and scaly skin with no re-growth of hair in the clipped areas accompanied by loss of hair in areas that became wet with the test chemical during administration. Autopsy at study termination showed no gross signs of damage in the internal organs. However, slight signs of pneumonia were observed in both the treated and control groups. Based on the study result, the author concluded that the acute dermal LD50 for the C12-C16 blend was greater than 10,000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU
Conclusions:
Dermal LD50 for C12-16 alpha olefin blend is >10,000 mg/kg.
Executive summary:

In an acute dermal penetration study, groups of 4 male albino rabbits were kept under observation for 7 days prior to study initiation. Prior to dosing, the animals were clipped free of hair over the entire trunk area. One half of the animals were further prepared for the study by making longitudinal epidermal abrasions that were sufficiently deep enough to penetrate the stratum corneum, but not deep enough to penetrate the derma and cause bleeding. All animals were wrapped with surgical gauze and covered with an impervious plastic film. Each animal was then dosed with 10 g/kg of C12 -16 Alpha Olefin blend introduced under the plastic film via a syringe and catheter. Following dosing, the animals were immobilised in stocks for 24 hours after which the plastic film, gauze and excess test material were removed. The animals were returned to their cages for a 14 day post treatment observation period. The test conditions generally complied with the guideline requirements for this study type. The study author reported that none of the treated rabbits died. Treated animals exhibited taut, dry and scaly skin with no re-growth of hair in the clipped areas accompanied by loss of hair that became wet with the test chemical during administration. Autopsy at study termination showed no gross signs of damage in the internal organs. However, slight signs of pneumonia were observed in both the treated and control groups. Based on the study result, the author concluded that the acute dermal LD50for the C12-C16 blend was greater than 10,000 mg/kg.

This study received a Klimisch rating of “reliable with restrictions” because it appears to adhere to OECD 402 guidelines.