Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 February 1980 - 29 February 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted in compliance with the Code of GLP, Federal Register, 43, 247, Dec. 22, 1978 and the study can be compared to the deleted OECD 401 guideline for testing acute oral toxicity (OECD earlier version 401, 1981).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
yes
Remarks:
10 male and 10 female rats, one dose tested
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes
Remarks:
Code of GLP, Federal Register, 43, 247, Dec. 22, 1978.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: TacN(SD)fBR (albino)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms (Germantown, N.Y.)
- Age at study initiation: no data
- Weight at study initiation: 180 to 280 grams
- Fasting period before study: yes, overnight
- Housing: singly in wire cages under standard laboratory conditions meeting the standards described in the 'Guide for the Care and Use of Laboratory Animals' (DHEW Publication No. (NIH) 78-23 Revised 1978).
- Diet: Purina Rodent Laboratory Chow 5001 ad libitum
- Water: ad libitum
- Acclimation period: seven days

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.1 ml/kg bw.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 males, 10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Weighing: pre-fast, dosing, and terminal.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: necropsy-tissues examined: lungs, heart, liver, spleen, kidney, adrenals, bladder, stomach, intestines. Other tissues examined grossly: the external carcass (fur, skin and orifices), peritoneal and pleural mucosa, internal mesentery.

Results and discussion

Preliminary study:
In a preliminary range finding assay in which two fasted rats (one of each sex) were treated by gavage at 5000 mg/kg bw., there were no deaths during the 72 hour observation period.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: No mortality noted at this dose level.
Mortality:
There were no deaths in 10 males and 10 females dosed with the test article.
Clinical signs:
There were no clinical signs in any animal dosed at 5000 mg/kg bw. All the animals appeared normal in health and behavior throughout the 14 day observation period.
Body weight:
The animals all gained weight in a normal pattern.
Gross pathology:
There were no signs indicative of toxicity in any of the ten animals necropsied at term. No visible lesions in the tissues examined.

Applicant's summary and conclusion

Interpretation of results:
other: criteria not met
Remarks:
according to EU CLP (EC 1272/2008 and its amendments)
Conclusions:
The LD50 for rats was in excess of 5000 mg/kg bw similar to OECD TG 401.
Executive summary:

The acute oral toxicity of the test substance was examined in a limit test equivalent to OECD TG 401. In a preliminary assay in which two rats were treated by gavage at 5000 mg/kg bw. Thereafter, ten male and ten female albino rats (TacN(SD)fBR) weighing between 180 and 280 grams were fasted overnight and were then dosed by gavage with 5000 mg/kg bw. of the test substance. In the preliminary assay no mortality occurred during the 72 h observation period. In the main test no mortality was seen, clinical signs and body weight gain were similar to controls.No other signs indicative of toxicity was seen. At necropsy, none of the animals had any signs indicative of systemic toxicity. The LD50 was in excess of 5000 mg/kg under the conditions of the current study.