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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to OECD 401 guideline study with acceptable restrictions [Body weight was only determined at the beginning of the study (OECD: weekly); Observation period: 7 days (OECD:14 days)] For read-across justification refer to section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
BASF-TEST: In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean body weight at study initiation:
259 g males/ 211 g females

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
DOSAGE PREPARATION:
- Stock solutions prepared:
30%
- Dose volume applied:
2500 mg/kg bw dose group: 8.33 ml/kg bw
3200 mg/kg bw dose group: 10.66 ml/kg bw
4000 mg/kg bw dose group: 13.33 ml/kg bw
5000 mg/kg bw dose group: 16.66 ml/kg bw
6400 mg/kg bw dose group: 21.4 ml/kg bw
Doses:
2500; 3200; 4000; 5000; 6400 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days;
- The animals were observed for mortality and clinical signs of toxicity;
- Frequency of observations: Several times on the application day, thereafter once each working day;
- Body weights were only recorded at the beginning of the study;
- Necropsy of survivors and animals which died performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Mortality:
- One female died in the 2500 mg/kg bw dose group; 9/10 animals died in the 3200 mg/kg bw dose group and all animals of the higher dose groups (see table 1).
Clinical signs:
- 2500, 3200 and 4000 mg/kg bw: directly after application: accelerated respiration, squatting posture, twitching, ataxia, red eyes, some animals showed light secretion, reluctance to move; the next day: squatting posture, contaminated fur, intermittened respiration, reluctance to move; fully reversible within 6 days
- 5000 and 6400 mg/kg bw: directly after application: accelerated respiration, squatting posture, twitching, ataxia, red eyes, some animals showed light secretion, reluctance to move; later: prone position
Body weight:
Body weights were not recorded during and at the end of the observation period
Gross pathology:
Animals which died:
- heart: acute dilatation, venous hyperemia
- liver: congestion
- gut: diarrhea like content
- stomach: dilatation
- kidneys: degeneration
Animals which were sacrificed:
- nothing abnormal detected

Any other information on results incl. tables

Table 1: Mortalities of rats after oral application

2500 mg/kg bw 3200 mg/kg bw 4000 mg/kg bw 5000 mg/kg bw 6400 mg/kg bw
1 h male  0/5 0/5 0/5 0/5 0/5
female 0/5 0/5 0/5 0/5 0/5
24 h male  0/5 3/5 5/5 5/5 5/5
female 1/5 5/5 5/5 5/5 5/5
48 h male  0/5 3/5 5/5 5/5 5/5
female 1/5 5/5 5/5 5/5 5/5
7 d male  0/5 4/5 5/5 5/5 5/5
female 1/5 5/5 5/5 5/5 5/5

Applicant's summary and conclusion