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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:
27.09.1972 - 03.10.1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973
Reference Type:
secondary source
Title:
Unnamed
Year:
1973

Materials and methods

Principles of method if other than guideline:
BASF test
The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage with an aqueous solution of the test substance.
The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.

The LD50 value was estimated on the basis of the observed mortalities.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Details on test material:
- CAS number (as cited in study report): 1854-26-8
- Name of test material (as cited in study report): Fixapret CPN, Dimethylolglyoxalmonourein
- Substance type: aqueous solution
- Physical state: liquid
- Purity: 45%
- Impurities (identity and concentrations): 0.5 -0.8% formaldehyde

Test animals

Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 255 (225-283) g males; 185 (154-204) g females

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2-30%
- Amount of vehicle: 1.54 - 5.55 cm3/animal
Doses:
232, 1856, 3712 and 7424 mg/kg b.w. (= approx. 200, 1600, 3200, 6400 mm3/kg; density of the 45% solution = 1.16 mg/mm3; density of the pure TS = 1.36 mg/mm3 )
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily observations for clinical signs; weighing only prior to application
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 424 mg/kg bw
Remarks on result:
other: Calculated for a concentration of 100% test substance, the LD50 is > 3341 mg/kg b.w.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 7 424 mg/kg bw
Remarks on result:
other: Calculated for a concentration of 100% test substance, the LD0 is >= 3341 mg/kg b.w.
Mortality:
not reported
Clinical signs:
not reported
Body weight:
not determined
Gross pathology:
nothing abnormal found

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification according to GHS criteria.