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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: well performed research study, conducted prior to OECD and GLP guideline implementation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Company guideline similar to OECD 401
Deviations:
not applicable
GLP compliance:
no
Remarks:
prior to GLP implementation
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Acetessig-m-xylidid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Fasting period before study: 15 - 20 h
- Observation period: 14 d

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
aqueous 0.5%
Details on oral exposure:
Dose:
4640, 3160, 2610, 2150, 1780, 1470, 1210, 1000, 681 mg/kg bw

Concentration in vehicle:
46.4, 31.6, 26.1, 21.5, 17.8, 14.7, 12.1, 10.0, 6.8 % (W/V)

DOSE VOLUME APPLIED:
10 ml/kg

Doses:
4640, 3160, 2610, 2150, 1780, 1470, 1210, 1000, 681 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
Probit

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 995 mg/kg bw
Based on:
test mat.
Mortality:
male:
4640 mg/kg bw: 4/5
3160 mg/kg bw: 4/5
2610 mg/kg bw: 3/5
2150 mg/kg bw: 3/5
1780 mg/kg bw: 1/5
1470 mg/kg bw: 3/5
1210 mg/kg bw: 0/5
1000 mg/kg bw: 2/5
681 mg/kg bw: 0/5

female:
4640 mg/kg bw: 4/5
3160 mg/kg bw: 3/5
2610 mg/kg bw: 4/5
2150 mg/kg bw: 3/5
1780 mg/kg bw: 2/5
1470 mg/kg bw: 3/5
1210 mg/kg bw: 1/5
1000 mg/kg bw: 1/5
681 mg/kg bw: 0/5
Clinical signs:
DYSPNEA, APATHY, ABNORMAL POSITION, ATAXIC GAIT, ATONY, MISSING PAIN REACTION, NARCOSIS LIKE STATE, CONVULSIVE GAIT, COAT RUFFLED, SKIN REDDISH, EXSICCOSIS, LACRIMATION, WEAK GENERAL STATE
Body weight:
Mean body weight

Dose group
(mg/kg bw) 4640 3160 2610 2150 1780 1470 1210 1000 681

male
(g) initial 160 300 160 210 160 250 160 260 160
13 d 254 360 244 293 245 326 260 257 261
female
(g) initial 160 170 160 180 170 180 170 190 150
13 d 146 198 212 231 217 215 219 222 204

Gross pathology:
animals died:
cardiac dilatation and hyperemia
liver: adipose degeneration
urinary bladder: haemorrhage
urine: blood-coloured
kidneys: loam-coloured
lung: sporadic oedematous

animals killed:
no abnormal findings

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
LD50: 1995 mg/kg bw
Executive summary:

The acute median lethal oral doses (LD50) for the rat were estimated to be:

Male and female combined:        1995 mg/kg bw