Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
red powder
Batch # : BRA1/285

Test animals

Species:
other: rat and mouse
Strain:
other: Wistar rats, CF1 mice
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 10 % gummi arabicum solution
Doses:
Rats: 900, 1700 and 2500 mg/kg bw
Mice: 1000, 1500, 2000 and 2500 mg/kg bw
No. of animals per sex per dose:
Rats: 6 animals per sex and dose
Mice: 10 animals per sex and dose

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
1 436 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Remarks:
rat
Effect level:
1 564 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Remarks:
mouse
Effect level:
1 750 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Remarks:
mouse
Effect level:
1 600 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Table 1: Mortality rates in rats and mice after a single oral application:

    Species                 Dose [mg/kg bw]
900     1000  1500  1700  2000  25000
 Mice (female)  n.t.  0/10  4/10   n.t.  6/10  10/10
Mice (male)   n.t.  2/10  4/10   n.t.  7/10  10/10
 Rats (female)  1/6   n.t.   n.t.  3/6   n.t.  6/6
 Rats (male)  2/6   n.t.   n.t.  3/6   n.t.  6/6

n.t. = not tested

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The above described study allows a formally valid classification in terms of the acute oral toxicity of Hydroxyethyl-2-nitro-p-toluidine. According to the results obtained, Hydroxyethyl-2-nitro-p-toluidine is harmful if swallowed.
Executive summary:

 The test substance, suspended in a 10 % gummi arabicum solution, was administered at 3 dose levels from 900 to 2500 mg/kg bw to rats and at 4 dose levels from 1000 to 2500 mg/kg bw to mice once by oral gavage. Mortality and clinical signs were checked daily for the 14-day observation period. Body weights were recorded weekly and all animals were submitted to a gross necropsy at the end of the observation period. Doses tested in the main study were based on a pretest in female mice (3 per test doses of 1, 2 and 4 g/kg bw), which revealed a median lethal dose between 1000 and 2000 mg/kg bw. The only clinical signs reported were reduced activity in both rats and mice. In both species the urine and extremities were coloured orange up to 24h after administration. Based on the observed mortality rates, the following LD50 figures were calculated by the method of Spearman-Kärber: 

LD50 rat ♀: 1436 mg/kg bw

LD50 rat ♂: 1564 mg/kg bw

LD50 mouse ♀: 1750 mg/kg bw

LD50 mouse ♂: 1600 mg/kg bw 

The available acute oral toxicity study was not performed according to the respective OECD guideline (OECD 401) but according to the recommendations by the FDA in place at that time. The study fulfils the formal GLP requirements. The investigations/data recorded are in line with or exceed the requirements described in OECD 401, e.g. with regard to number of animals in the study with rats. Furthermore a second rodent species (mouse) was also investigated. The study is therefore considered as valid without restrictions and allows a scientifically sound evaluation of the acute oral toxicity of HYDROXYETHYL-2-NITRO-p- TOLUIDINE