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

Data source

Referenceopen allclose all

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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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
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:
onset: 0-4 hours: hypoactivity, tremor, convulsions salivation, prostration death (see section"remarks on results including tables and figures")
Body weight:
174 -186 g initial body weight; terminal body weight ca 224 g
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

RS-Freetext:
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

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