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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:
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

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:
There was no sign of reaction to treatment.
Body weight:
The animals achieved anticipated bodyweight gains.
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.

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