Registration Dossier

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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 40%
- Lot/batch No.: 95083250

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: Males 146-180g, females 132-195g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
-Post exposure period: 14 days
Doses:
Concentrations: 800, 1265, 2000 mg/kg
Volumes: 800 mg/kg - 1.65 ml/kg, 1265 mg/kg - 2.60 ml/kg, 2000 mg/kg - 4.11 ml/kg
No. of animals per sex per dose:
800 mg/kg - 5 females
1265 mg/kg - 5 females
2000 mg/kg - 5 males and 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
1 208 mg/kg bw
Mortality:
Mortality: 2 females during day of dosing and 1 female one day after dosing with 1265 mg/kg
5 females 1 and 2 days after dosing with 2000 mg/kg
2 males during day of dosing and 2 males one daay after dosing with 2000 mg/kg
Clinical signs:
Signs of systemic toxicity like ataxia, hunched posture, lethargy, decreased respiratory rate and laboured respiration with additional signs of ptosis were noted in all dosed groups. Incidents of systemic toxicity like pilo-erection and loss of righting reflex were noted in all animals in the 1265 or 2000 mg/kg groups. An isolated incident of splayed gait was noted in one female treated with 800 mg/kg and clonic and tonic convulsions in one female treated with 1265 mg
Body weight:
Surviving animals showed expected gain during the study
Gross pathology:
Abnormities noted at necropsy of animals that died during the study were haemorrhagic or abnormally red lungs, dark liver, or patchy pallor of the liver, dark kidneys and haemorrhage of the gastric mucosa and slight haemorrhage of the small intestine was also noted in one female treated with 2000 mg/kg. Scattered white foci on the non-glandular epithelium of the stomach were noted in one female treated with 1265 mg that was killed at the end of the study. No abnormities were noted at necropsy of all other animals that were killed at the end of the study

Applicant's summary and conclusion

Conclusions:
According to the EU classification criteria Sodium Pyrithion should be classified as harmful and the symbol Xn and risk phrase R22- harmful if swallowed. The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.