Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well perforemd study following scientific prinziples performed prior to GLP and OECD guideline implementation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: company guideline similar to OECD 401
GLP compliance:
no
Remarks:
performed prior to GLP implementation
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 200 - 300 grams
- Fasting period before study: twenty-four hours
- Housing: common cage
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
2000, 4000, 8000, 10000, 12500, 16000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: No postmortem, or histopathology examinations were performe

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
8 550 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
7 450 mg/kg bw
Based on:
test mat.
Mortality:
male

dose level / mortality

2000 mg/kg bw.: 0 of 5
4000 mg/kg bw.: 0 of 5
8000 mg/kg bw.: 2 of 5
10000 mg/kg bw.: 3 of 5
12500 mg/kg bw.: 4 of 5
16000 mg/kg bw.: 5 of 5


female

dose level / mortality

2000 mg/kg bw.: 0 of 5
4000 mg/kg bw.: 1 of 5
8000 mg/kg bw.: 2 of 5
10000 mg/kg bw.: 4 of 5
12500 mg/kg bw.: 5 of 5
16000 mg/kg bw.: 5 of 5
Clinical signs:
The animals dosed at levels of 2000 mg/kg bw. did not exhibit any symptoms of toxicity.
At 4000 mg/kg bw. and 8000 mg/kg bw. levels, the animals were lethargic with ruffled coats after dosing.
All animals dosed at 10000 mg/kg bw. and above were extremely lethargic (almost comatose). Hematuria was noted prior to death in the animals which succumbed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 male: 8550 mg/kg bw.
LD50 female:7450 mg/kg bw.

These values are above the threshold for classification and thus do not meet criteria for classification according to REGULATION (EC) No 1272/2008.
Executive summary:

Male and female albino rats were subjected to test acute oral toxicity according to a company guideline similar to OECD 401. The test substance was administered by gavage at dose levels of 2000, 4000, 8000, 10000, 12500, 16000 mg/kg bw. (vehicle: propylene glycol). Based on the mortality rates detected LD50 values were calculated as follows:

LD50 male: 8550 mg/kg bw. LD50 female:7450 mg/kg bw.