Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 June 2006 - 18 July 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
yes
Remarks:
Storage of the vehicle at room temperature instead of refrigerator. No effect presumed on outcome of the study.
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technical product

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Young healthy adult rats, 8-12 weeks old, body weight at start: 172-194 g, acclimatisation period: 13-15 days.
Husbandry: group caging (4 animals per cage), 12 h light / 12 hours dark; 19-25°C, 30-70% relative humidity.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
single dose
Doses:
Sighting study 1: 2000 mg/kg bw (single female rat)
Sighting study 2: 300 mg/kg bw (single female rat)
Main study: 300 mg/kg bw (four female rats)
No. of animals per sex per dose:
Sighting study 1: 1 female rat, one dose
Sighting study 2: 1 female rat, one dose
Main study: 4 female rats, one dose
Control animals:
no
Statistics:
not necessary

Results and discussion

Preliminary study:
Sighting study 1 with one female rat, dosage 2000 mg/kg bw: animal found dead after 1 day.
Sighting study 2 with one female rat, dosage 300 mg/kg bw: no evident toxicity and no moratlity.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Sighting study 1: 1/1
Sighting study 2: 0/1
Main study: 0/4
Clinical signs:
Sighting study 1: decreased activity, tremor, incoordination, hunched back, decreased righting reflex, narrow eye aperture, paleness, piloerection, dyspnoea. lachrymation. First symptoms appeared 2 h after treatment.
Sighting study 2, main study: no visible symptoms.
Body weight:
Sighting study 1: not less than at starting.
Sighting study and main study: weight development was undisturbed.
Gross pathology:
No macroscopic changes in all animals.
Sighting study 1: Reddish mottled lungs as indication of an acute circulatory insufficiency during death of the animal.
Sighting study 2 and main study: Pinprick-sized haemorrhages in the lungs (sighting study: 1/1, main study: 2/4)m, hydrometra in the uterus (main study: 2/4).

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
2000 mg/kg bw of the test item caused mortality in female Wistar rat (1/1) after single oral administration.
300 mg/kg of the test item caused no adverse effect and no mortality in female Wistar rat (0/5) after single oral administration.
The test item was ranked into GHS class 4 and into EPA category III ("Caution") and is considered harmful if swallowed according to EU Commission Directive 2001/59/EC (R22).
Executive summary:

An acute oral toxicity test (fixed dose method) according to OECD 420 was performed on the test item.

At 2000 mg/kg bw, one female rat was dead within 1 day after one single oral adiminstration. At 300 mg/kg bw, all five female rats tested survived the whole observation period of 14 days. The acute oral toxicity of the test item against female Wistar rats was estabhlished between 300 and 2000 mg/kg bw.

The test item was rankec into the GHS class 4 and into the EPA Category III ("Caution").

The test item was considered harmful if swallowed (R22) according to EU Commission Directive 2001/59/EC.