Oct-2-ene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-03-02 to 1982-04-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because the study closely followed OECD 402 guidelines and was GLP compliant.

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Study conducted before guideline introduced

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Study conducted before guideline introduced

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

111-66-0

Molecular formula:

C8H16

Details on test material:

- Name of test material (as cited in study report): Neodene 8 alpha olefin
- Substance type: C8 alpha olefin
- Physical state: Liquid
- Lot/batch No.: Sample number 618A
- Stability under test conditions: Stated that stability was confirmed.

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
- Weight at study initiation: Approximately 3000 grams
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4-21.1°C
- Humidity (%): 25-60%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From: 1982-03-02 To: 1982-04-06

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 4 x 4 inch
Type of wrap if used: aluminium foil taped in place then overwrapped with an elastic Ace bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With a moist towel
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg
- Constant volume or concentration used: Yes

Duration of exposure:

24 hours

Doses:

2 mL/kg

No. of animals per sex per dose:

Eight animals/sex/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 1, 2, 4, 6, and 24 hours after exposure, then twice daily for 14 days. Animals were weighed at study initiation, 7 days, and 14 days.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, and skin irritation

Statistics:

An independent T-test with p<0.05 was used on body weight data.

Results and discussion

Preliminary study:

None performed.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 mL/kg bw

Remarks on result:

other: Equivalent to > 1430 mg/kg

Mortality:

No animals died over the 14 day observation period.

Clinical signs:

other: There were no clinical signs of toxicity related to treatment.

Gross pathology:

The only findings at necropsy were related to the treatment site and included white crust material on the skin and fur (considered dried test material), alopecia, abrasions, erosion, and in one animal cutaneous firmness.

Other findings:

- Other observations: There was mild to moderate erythema and oedema following the removal of the wrappings at 24 hours. Mild irritation was still present at 14 days. There was no difference in the level of irritation between the intact and abraded skin.

Any other information on results incl. tables

 

Summary of Skin Irritation (Average and Range)
	24 hours		14 days
	erythema	oedema	erythema	oedema
Treated intact skin	1.6 (0 to 2)	1.4 (0 to 3)	0.9 (0 to 2)	0.4 (0 to 1)
Control intact skin	0.1 (0 to 1)	0.0	0.0	0.0
Treated abraded skin	0.8 (0 to 2)	1.4 (1 to 4)	1.3 (0 to 2)	0.5 (0 to 1)
Control abraded skin	0.0	0.4 (0 to 1)	0.0	0.0

 

 

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

LD50 is greater than the maximum concentration tested (i.e., 1430 mg/kg) Criteria used for interpretation of results: EU

Conclusions:

Acute dermal LD50 was > 2.0 mL/kg.

Executive summary:

In an acute dermal toxicity study, groups of New Zealand rabbits (8/sex) were dermally exposed to 2 mL/kg of undiluted Neodene 8 alpha olefin (i.e., 1 -octene) to a 4 x 4 inch section for 24 hours. Four of the animals per sex and treatment had their skin abraded prior to treatment. Animals were then observed for 14 days. There was no treatment-related lethality, clinical signs of toxicity, changes in body weight, or necropsy findings. The only notable finding was mild to moderate skin irritation following the removal of the wrappings at 24 hours. Mild skin irritation was still present on day 14. Skin irritation was not effected by abrading the skin. The dermal LD50 was determined to be greater than 2.0 mL/kg in males and females. This study received a Klimisch score of reliable without restrictions because the study closely followed OECD 402 guidelines and was GLP compliant.