Alcohols, C7-9

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD guideline, in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C6-12

EC Number:

271-642-9

EC Name:

Alcohols, C6-12

Cas Number:

68603-15-6

IUPAC Name:

octan-1-ol

Details on test material:

- Name of test material (as cited in study report): Tradename Linevol 79, C6-12 alcohols Type C

- Physical state: a clear colourless liquid

- Storage condition of test material: cool conditions (not exceeding 15C), protected from light in the original container.

Test animals

Species:

rat

Strain:

other: CD strain rat (remote Sprague-Dawley origin)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Margate, Kent, UK
- Age at study initiation: young adults
- Weight at study initiation: males 213-306, females  204-236.
- Housing:stainless steel grid cages. 5 animals/sex/cage.
- Diet: complete pelleted rodent diet, ad libitum
- Water: tap water, ad libitum
- Acclimatization period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%):40-70
- Air changes (per hr): min. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From:27.09.1995 To: 19.10.1995

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Remarks:

undiluted

Details on dermal exposure:

TEST SITE
- Area of exposure: the dorsum between limb girdles, 5cm X 5cm

- Type of wrap if used: gauze patch occluded with aluminium foil held in place with  waterproof plaster bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle wiping with wet disposable tissues
- Time after start of exposure: 24h


.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5M, 5F

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were conducted daily throughout the study. The bodyweight of each animal was recorded on the day prior to treatment, the day of treatment, Day 8 and Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: A detailed external and internal examination was carried out at necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: There was no sign of reaction to treatment.

Gross pathology:

Necropsy findings were unremarkable. Fluid distension of the  uterus in one female was not considered treatment related as this is a  common finding among female CD rats.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 (24 hour occluded) for Linevol 79 was found to be >2000 mg/kg in this limit test.