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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 observation  considered treatment related was hypoactivity in 2 rats during the first  3 hours after dosing. 
Body weight:
The rats of both treated and control groups gained  in body weight over the 14 day observation period and there were no  treatment related differences in body weight gain.
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.