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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
According to BASF-internal standard: Five Sprague-Dawley rats per sex per dose were exposed to the test substance dissolved in carboxymethyl cellulose (with 2-3 drops Cremophor EL) via oral gavage. Animals received 1600, 3200, 4000 and 6400 mg/kg bw. After an observation of 7 days animals were necropsied.
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): Dioxyäthyl-anilin

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: Males: 143 - 169g; Females: 142 - 167g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
with 2-3 drops Cremophor EL
Details on oral exposure:
The test substance was administered in concentrations of 2, 16 and 30%
Doses:
1600, 3200, 4000 and 6400 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 400 mg/kg bw
Based on:
test mat.
Mortality:
- 1600 mg/kg: no deaths observed
- 3200 mg/kg: 3/5 females died within 24 hours. 0/5 males died within 7 days
- 4000 mg/kg: 1/5 females died within 1 hour, the remaining females died within a day. 2/5 males died within 24 hours, 4/5 males were dead after 7 days.
- 6400 mg/kg: 4/5 females and 2/5 males died within 1 hours, the remaining animlas died within a day
Clinical signs:
Immediately after application until 20 minutes after application dyspnea, partly atony and staggering, narcotic-like state, scretion from snounts was observed. All symptoms were absent within 5 days.
Body weight:
Normal body weight gain was observed.
Gross pathology:
Acute heart dilatation and congestive hyperemia, dilated stomach with liquid content, diarrheic intestine content, splenomegaly were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information