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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:
03.11.1980-
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: other: regulatory procedure
GLP compliance:
yes
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
Alcohols, C9-11
EC Number:
266-367-6
EC Name:
Alcohols, C9-11
Cas Number:
66455-17-2
IUPAC Name:
decan-1-ol
Details on test material:
- Name of test material (as cited in study report): C9-11 alcohols Cas# 66455-17-2 (Neodol 91) 84% linear monobranched at the 2 position

- Physical state: a clear, moderately viscous liquid

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Portage, Michigan, US
- Age at study initiation: Not reported.
- Weight at study initiation: males 213.9 + or - 8.1g; females 170 + or -  10.4 g (fasted weights for treated animals)
- Fasting period before study: overnight
- Housing: individual polycarbonate/wire mesh cages
- Diet: ad libitum, except during exposure
- Water: yes, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 23.3
- Humidity (%): average 54.9
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5ml/kg

Doses:
5 ml/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed:  All rats were necropsied at the end of the  observation period.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs were recorded hourly for 6 hours after  dosing then at 24 hours and twice daily throughout the 14 day observation  period.  Bodyweights were recorded the day before dosing and at 7 and 14  days. A fasted body weight was taken prior to dosing and used for  calculation of the dosage.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Mortality:
There were no mortalities in either test or control animals.
Clinical signs:
other: All treated animals had diarrhoea at 0.5 -1.5 hours after  dosing, while 4/5 males and all females had polyuria by 24 hours after  dosing. Among control animals one female had polyuria. All animals  appeared normal by 54 hours post-dosing. The only other 
Gross pathology:
There was no observable pathology in either test or  control animals.
Other findings:
POTENTIAL TARGET ORGANS: No conclusions.
SEX-SPECIFIC DIFFERENCES: None

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 of Neodol 91 is >5 ml/kg (>4000 mg/kg using lowest value of density range 0.8 g/cm3 see chapter 2.3). Signs of intoxication were diarrhoea and hypoactivity. Gross necropsy findings were unremarkable.