m-cresol

Acute Toxicity: oral

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: no information on strain used , no information on statistical evaluation given

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Bio fax data sheet: m-cresol

Author:

Industrial Bio-test Laboratory Inc.

Year:

1969

Bibliographic source:

Industrial Bio-test Laboratory Inc, Northbrook, Ill/USA, Data sheet no 3-5/69

Reference 2

Reference Type:

publication

Title:

Die Stoffklassifizierung nach toxikologischen Kriterien auf der Grundlage molekularer Strukturen.

Author:

Koch R et al

Year:

1984

Bibliographic source:

Z. Ges. Hyg. 30, 199-203 (review)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Method: single application by gavage, 5 rats/dose group, 4 doses, undiluted liquid, time of recovery: up to 14 days, observations for signs of toxicity, necropsy at the end of the observation time.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

m-cresol

EC Number:

203-577-9

EC Name:

m-cresol

Cas Number:

108-39-4

Molecular formula:

C7H8O

IUPAC Name:

m-cresol

Details on test material:

IUCLID4 Test substance: other TS: m-cresol, purity not given, M.P.: 11-12 C, B.P.: 202,8 C

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: none

Details on oral exposure:

no further data

Doses:

147, 215, 316, 464 mg/kg bw.

No. of animals per sex per dose:

5 males/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily; weighing at the beginning and at the end
:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross autopsy of survivors and decedents

Statistics:

yes, method not described

Results and discussion

Preliminary study:

no data

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 242 mg/kg bw

95% CL:

>= 190 - <= 308

Remarks on result:

other: Clinical signs included hypoactivity, salivation, tremors and convulsions

Mortality:

see section"remarks on results including tables and figures".

Clinical signs:

other: onset: 0-4 hours: hypoactivity, tremor, convulsions salivation, prostration death (see section"remarks on results including tables and figures").

Gross pathology:

survivors: no significant findings
decedents: inflammation of the gastrointesinal tract, hyperemia of lungs, liver, kidneys
see section"remarks on results including tables and figures"

Other findings:

no further data

Any other information on results incl. tables

dosage onset of sympt. mortality mortality
mg/kg bw 0-4 hrs 0-4hrs day3 day6 day7 cumulat.
147        S 0/5
215        S 1/5 1/5 2/5
316        S 3/5 1/5 4/5
464        S 4/5 1/5 5/5

S=signs of intoxication: Hypoactivity, H tremors, convulsions, salivation, prostration
survivors: recovery within observation time, gross necropsy: no significant findings
decedents, gross necropsy: inflammation of the gastrointestinal tract, hyperemia of lungs, liver and kidneys.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Executive summary:

Single oral application of undiluted testsubstance by gavage to 5 rats/dose group and an observation time up to 14 days resulted in an LD50 value of 242 mg/kg bw.