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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-09-13 to 1993-11-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restrictions because the study closely followed GLP and OECD guidelines. The study is well documented and scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
This study follows the Pesticide Assessment Guideline, Subdivision F: Hazard Evaluation: Human and Domestic Animals, Series 81-2, U.S. EPA 540/9-84-014.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetradecene
EC Number:
248-130-9
EC Name:
Tetradecene
Cas Number:
26952-13-6
Molecular formula:
C14H28
IUPAC Name:
Tetradecene
Details on test material:
- Name of test material (as cited in study report): Sample 1205-47
- Substance type: C14 isomerised olefin
- Physical state: Clear colourless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas
- Age at study initiation: Young adult 3 to 6 months
- Weight at study initiation: Males: 2.625 to 2.825 kilograms; Females: 2.475 to 2.650 kilograms
- Housing: Suspended, wire bottom, stainless steel; one animal per cage
- Diet (e.g. ad libitum): Purina Rabbit Chow; fed in measured amounts
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: 5 days


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal surface of the trunk
- % coverage: 10%
- Type of wrap if used: Surgical gauze covered with non-irritating adhesive tape which was further covered with semi-permeable dressing and again wrapped with non-irritating adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with room temperature tap water and a clean wet cloth
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.47 mL/kg equivalent to 2020 mg/kg
- Concentration (if solution): Not applicable
- Constant volume or concentration used: yes

Duration of exposure:
24 hours
Doses:
2020 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 3, and 6 hours after exposure and daily until day 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weight
Statistics:
Statistical analysis, if performed, is not presented in the study report.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 020 other: mg/kg
Mortality:
No mortality was observed during the course of the study.
Clinical signs:
The only effects observed included loss of body weight gain in one treated female between days 0 to 7 and slight polyuria in one male between 10 to 14 days.
Body weight:
No changes in body weight were noted.


Gross pathology:
No observable abnormalities were noted.

Any other information on results incl. tables

Body weight gain was not affected from exposure to tetradecene. However, one treated female failed to gain weight between 0 to7 days. Toxicological and pharmacological signs were not noted. There were no signs of dermal irritation during the 14 day observation period. The only notable observation was slight polyuria in one male between 10 and 14 days. Gross necropsy at study termination revealed no observable abnormalities. None of the treated animals died during the course of the study. Based on these results, the LD50for tetradecene in albino rabbits is > 2020 mg/kg (2.47 mL/kg).

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information: LD50 is greater than 2020 mg/kg
Conclusions:
The acute dermal LD50 for tetradecene is greater than 2020 mg/kg.
Executive summary:

In acute dermal toxicity study, five male and female New Zealand White rabbits were clipped free of hair on the dorsal surface of the trunk and treated with 2020 mg/kg (2.47 mL/kg) undiluted tetradecene that was held in contact with the skin for 24 hours. After 24 hours the animals were observed for toxicological and pharmacological effects, and mortality at 0.5, 3, and 6 hours after treatment and at least once daily until study termination on day 14. Animals were sacrificed for necropsy on day 14.

 

Body weight gain was not affected from exposure to tetradecene. However, one treated female failed to gain weight between 0 to 7 days. Toxicological and pharmacological signs were not noted. There were no signs of dermal irritation during the 14 day observation period. The only notable observation was slight polyuria in one male between 10-14 days. Gross necropsy at study termination revealed no observable abnormalities. None of the treated animals died during the course of the study. Based on these results, the LD50for tetradecene in albino rabbits is > 2020 mg/kg (2.47 mL/kg).

 

This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because the study closely followed GLP and OECD guidelines. The study is well documented and scientifically acceptable. This study will influence the DNEL(s).