Hexacos-1-ene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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

Test material information

Constituent 1

Reference substance name:

Tetradecene

EC Number:

248-130-9

EC Name:

Tetradecene

Cas Number:

26952-13-6

IUPAC Name:

tetradec-1-ene

Details on test material:

This substance is very similar in structure to the substance being registered.

- 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:

other: 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.

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:

not classified

Remarks:

Migrated information 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:

The acute dermal LD50 for tetradecene is greater than 2020 mg/kg.

Executive summary:

Justification for Read Across

Several criteria justify the use of the read across approach to fill data gaps for linear alpha olefin substances using single carbon number isomerised olefin analogues.  Studies indicate that changing the carbon number, the location of the double bond, or adding branching to olefins does not measurably alter their respective toxicological effects on mammalian health endpoints. Single carbon number isomerised olefins were not acutely toxic via oral or dermal routes of exposure in animal studies and are therefore considered to have minimal acute toxicity potential. No adverse effects on the F0 or F1 generation were reported at the highest dose tested from a 42-53 day reproduction/developmental toxicity screening study in rats with octadecene (C18). The toxicological profile for single carbon number isomerised olefins, outlined above, indicates a low hazard potential for human health. There do not appear to be any significant toxicological differences between single carbon number isomerised olefins and linear alpha olefins. Therefore, read across between these two categories is justified.

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).