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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:
23 Sep - 16 Oct 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets basic scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF Test
In principle, the methods described in OECD Guideline 401 were used.
2 and 5 rats per dose respectively were treated by gavage with preparations of the test substance in 0.5 % CMC. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study, as it was needed for determination of dose, and at test termination. The clinical signs and findings were reported in summary form.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium acrylate
- Analytical purity: approx. 99 % (not stabilised)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Mean weight at study initiation: 191 g (males); 190 g (females)


ENVIRONMENTAL CONDITIONS
no details reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous suspension in 0.5 % CMC
Details on oral exposure:
VEHICLE
- Concentration in vehicle: aqueous suspension in 0.5 % CMC


MAXIMUM DOSE VOLUME APPLIED: 2.0 mL/animal

Doses:
2000, 4000, and 5000 mg/kg bw
No. of animals per sex per dose:
2 (2000, and 4000 mg/kg bw) and 5 (5000 mg/kg bw), respectively
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days (2000 and 4000 mg/kg bw) and 14 days (5000 mg/kg bw)
- Frequency of observations and weighing: Body weight determination of groups was performed at test start and termination. Lethality and clinical signs of toxicity were observed daily with the exception of weekends and holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no statistics were performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred at any dose level.
Clinical signs:
No clinical signs of toxicity were observed at any dose level.
Body weight:
The mean body weight of groups increased at a normal rate during the observation period.
Gross pathology:
At necropsy of survivors, no gross-pathological abnormalities were detected.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU