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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Conducted prior to the adoption of OECD test guidelines.
Deviations:
yes
Remarks:
Limited detail on test substance, and methodology.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: Males: 230 - 250 g. Females: 210 - 225 g.
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: No data.
Doses:
2000, 2510, 3160 and 3980 mg/kg bw (as a 25 % aqueous solution).
No. of animals per sex per dose:
Two or three depending on dose (five in total/dose).
Control animals:
no
Details on study design:
- Duration of observation period following administration: No data, but at least four days.
- Frequency of observations and weighing: Not stated
- Necropsy of survivors performed: No
- Other examinations performed: clinical signs, and gross pathology.
Statistics:
LD50 calculated by a modification of the method of E.J. de Beer (no further detail, calculation not presented).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 910 mg/kg bw
95% CL:
>= 2 530 - <= 3 345
Mortality:
No deaths at the lowest dose of 2000 mg/kg bw. There were one, two and five deaths in the 2510, 3160 and 3980 mg/kg bw groups, respectively. Survival time was several hours to four days, with most death occurring "overnight" (it is not clear if this means the night after the dosing).
Clinical signs:
Weakness in one to two hours with diarrhoea, salivation and tremors.
Body weight:
Body weights do not appear to have been measured apart from prior to dosing.
Gross pathology:
Inflammation of the gastrointestinal mucosa as well as liver and renal hyperaemia.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a well conducted acute oral study (reliability score 2), conducted according to a protocol similar to the now deleted OECD 401, but not to GLP, an LD50 of 2910 mg/kg bw was determined for Dequest 2000 in the rat.
Executive summary:

ATMP-H (Dequest 2000) was administered to Sprague-Dawley rats (two or three per sex depending on dose; five total) as aqueous solutions at doses of 2000, 2510, 3160 and 3980 mg/kg bw, by oral gavage. Observations were made for clinical signs and the viscera of the animals that died were examined macroscopically. There were 0, 1, 2 and 5 deaths, respectively. Survival time was several hours to four days with most deaths occurring "overnight". Toxic symptoms included weakness in one to two hours with diarrhoea, salivation and tremors. At macroscopic examination inflammation of the gastrointestinal mucosa as well as renal and liver hyperaemia were observed. The LD50 for the test substance was calculated to be 2910 mg/kg bw.