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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:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
other: OECD single dose oral toxicity (limit) test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
2,2-bis(bromomethyl)-1,3-propanediol (CAS No. 3296-90-0)
Purity: 98.96%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Age: 5-8 weeks old (bodyweight 136-153g males, 136-146g females)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
Volume administrated: 10 ml/kg
Post dose observation period: range finding study: 5 days Main study: 14 days
Doses:
2000 mg/kg
No. of animals per sex per dose:
Range finding study: 1 male, 1 female Main study: 5 males, 5 females
Control animals:
no
Details on study design:
The method used followed that described in the OECD guidelines for testing chemicals (1987) No. 401 "Acute oral Toxicity" referenced as Method B1 in the Comission Directive 84/449/EEC. Following a range finding study, a group of ten fasted rats (5 males and 5 females) was given a single oral dose of test material, as a suspension in archis oil B.P. at a dose level of 2000mg/kg bw. The animals were observed for 14 days after the day of dosingand were killed for gross pathological examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Range finding study: There were no deaths.
Main study: Three animals (one male and two females) were found dead thirty minutes or one hr after dosing
Clinical signs:
Range finding study: Common signs of systemic toxicity noted were hunched posture, lethargy, ataxia, laboured respiration,decreased respiratory rate and ptosis with additional signs of pilo-erection, loss righting reflex, red/brown staining around the eyes, vocalisation and increased lacrimation.
Based on this information a dose level of 2000 mg/kg bodyweight was selected for the main study.

Main study:
Common signs of systemic toxicity noted were coma, laboured respiration, hunched posture and lethargy with additional signs of ataxia, ptosis and decreased respiratory rate. Isolated incidents of loss of righting reflex were noted in two animals. Surviving animals appeared normal one or two days after dosing.
Body weight:
Surviving animals showed expected gain in bodyweight during the study
Gross pathology:
Main study: abnormalities noted at necropsy of animals that died during the study were dark liver, dark kidneys and slight haemorrhage of the gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal dose (LD50) was found to be greater than 2000 mg/kg bodyweight.