2-(N-methyl-p-toluidino)ethanol

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(N-methyl-p-toluidino)ethanol

EC Number:

220-638-5

EC Name:

2-(N-methyl-p-toluidino)ethanol

Cas Number:

2842-44-6

Molecular formula:

C10H15NO

IUPAC Name:

2-[methyl(4-methylphenyl)amino]ethan-1-ol

Test material form:

liquid: viscous

Specific details on test material used for the study:

Firstcure MHPT, was received September 22th, 1999. The test substance was a tan semi-solid and was stored at room temperature (approxitnately 22 °C). All chemical analyses and documentation pertaining to the characterization (i.e., stability and purity) of the bulk test substance were the responsibility of the Sponsor. The Sponsor's Material Safety Data Sheet indicated that the test substance was stable.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female Sprague-Dawley rats (Crl:CD RBR), approxitnately 7.5 weeks of age, were purchased from Charles River Laboratories, Kingston, NY, for use in this study. The animals were received on October 20, 1999 and a randorn sample (25%) of the shippient weighed 162-197 g the next day. The rats were held in quarantine for two weeks during which time they were observed daily for survival. At the end of the quarantine period, the rats were examined carefully to ensure their health and suitability as test subjects. Rats selected for the study were identified by a uniquely numbered metal tag inserted through the pinna of the right ear and by a cage card bearing the corresponding identification number.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

2 g/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male rat died during the study (Day 3).Mortality incidences are summarized in Table 1. One male rat died during the study (Day 3).

Clinical signs:

other: Clinical signs observed during the study included hypoactivity, redness around eyes, lacrimation, salivation, discoloration around mouth, redness around nose fur, discoloration,inguinal fur, rales and discolored paws. All surviving animals appeared day 5

Gross pathology:

Dark red adrenal glands were observed in the male rat that gross lesions were observed in any surviving rat at at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the acute oral median lethal dose (LD50) of MHPT in male and female rats was greater than 2 g/kg of body weight.

Executive summary:

MHPT was administered as a 20% (w/v) solution in corn oil by oral gavage to one group of five male and five female Sprague-Dawley rats in a single dose of 2 g/kg of body weight. Rats were observed for 14 days after test substance administration. One male rat died during the study (Day 3). Clinical signs observed during the study included hypoactivity, redness around eyes, lacrimation, salivation, discoleration around mouth, redness around nose fur, discolored inguinal fur, rales and discolored paws. All surviving animals appeared normal by Day 5 and remained so for the duration of the study. All surviving rats gained weight during the study and no gross lesions were observed inatry of these rats at necropsy. Dark red adrenal glands were observed from the one male rat that died. Based on the results of this study, the acute oral median lethal dose (LD50) of MHPT in male and female rats was greater than 2 g/kg of body weight.