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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Well documented and conducted study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Tradename Lorol 8

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Winkelmann, Hanover, Germany

- Weight at study initiation: mean body weight males, 137, females 127

- Fasting period before study: fasted, time not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: as an aqueous suspension
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 25% aqueous suspension at a constant volume of 20 ml/kg.

Doses:
5 g/kg single dose level
No. of animals per sex per dose:
5M, 5F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:  Body weights were recorded prior to dosing and at  24 hours, 1 week and 2 weeks after dosing. 

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs were observed particularly during the first 24 hours after dosing.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
There were no deaths during the course of the study.
Clinical signs:
During the first 24 hours all test animals showed some decrease in actvity and piloerection.  No adverse effects were observed during the 14 day observation period.
Body weight:
The animals showed a gain in body  weight at all measurement points during the 14 day observation period.
Gross pathology:
The were no abnormal findings.
Other findings:
No potential target organs identified, no sex xpecific differences detected.

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 Lorol 8 was >5g/kg when applied as an aqueous suspension. Clinical signs of intoxication were confined to slight sedation and piloerection during the first 24 hours following dosing. There was no remarkable gross pathology at necrospy and no indication of specific target organ toxicity.