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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 and 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 401 (Acute Oral 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:
Tradename Linevol 79, C6-12 alcohols Type C

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 Ltd, Margate, Kent, UK
- Age at study initiation: 5 weeks approx.
- Weight at study initiation: males 116-130 g; females 119-130g.
- Fasting period before study:over night
- Housing:stainless steel grid changes, five animal/sex/cage.
- Diet: complete, pelleted rodent diet, ad libitum
- Water: tap water, ad libitum

 


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 42-62
- Air changes (per hr): minimum of 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: Females: From:27.09.1995 To: 20.10.1995
Males: From:11.10.1995 To: 01.11.1995

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: maize oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10ml/kg in maize oil
Doses:
2 g/kg
No. of animals per sex per dose:
10M, 10F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weight of each animal was recorded on the day prior to dosing, the day of dosing, day 8 and 15. On day 15, rats were sacrificed and subjected to a gross necropsy consisting of a detailed external and internal examination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: . All animals were autopsied at the end  of the study, larger organs were sectioned and the  gastro-intestinal  tract opened at intervals for examination of the mucosal surface. There  was no histopathological examination

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:
Hunched posture and piloerection were observed in male animals between 30 minutes and 3 hours after dosing. The animals were fully recovered by day 2. There were no systemic signs of reaction to treatment amongst the females.
Body weight:
All animals achieved aniticipated bodyweight gains.
Gross pathology:
Necropsy revealed no significant macroscopic lesions.
Other findings:
POTENTIAL TARGET ORGANS: None indicated.
SEX-SPECIFIC DIFFERENCES: Males may be rather more susceptible as they  exhibited some signs of intoxication while females did not. However the  females may have been slightly older than the males given that the weight  range was similar in both sexes. There were no mortalities in either sex.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The rat oral LD50 for Linevol 79 is >2 g/kg. Signs of intoxicaton consisted of hunched appearance and piloerection on dosing day. There were no significant macrosopic lesions.

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