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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

There is no study according to the current guideline but the given information is sufficient to evaluate this endpoint.
The oral LD50 of undiluted o-cresol in rats is 121 mg/kg bw and the dermal LD50 for rabbits is 1380 mg/kg bw (Ind Bio-test Lab Inc 1969). The data base on acute inhalation toxicity of o-cresol is very limited and does not allow final conclusion.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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: individual animal data not given
Principles of method if other than guideline:
5 male rats/dose, observed for symptoms and mortality up to 10-14 days, afterwards gross autopsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
no further data
Route of administration:
oral: gavage
Vehicle:
other: undiluted
Details on oral exposure:
no further data
Doses:
68, 100, 147, 215 mg/kg bw
No. of animals per sex per dose:
5 male rats/dose
Control animals:
no
Details on study design:
no further details
Statistics:
yes, but method not mentioned
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
121 mg/kg bw
Remarks on result:
other: signs of intoxication included hypoactivity, tremor, convulsions, salivation, dyspnea, prostration within 4 hours post dosing
Mortality:
68 mg/kg bw: no deaths but signs of intoxication; recovery within 2 days
100 mg/kg bw: mortality: 2/5; survivors recovered within 4 days
147 mg/kg bw: mortality: 3/5; surviors recovered within 6 days
215 mg/kg bw: mortality: 5/5
Clinical signs:
other: All animals showed signs of intoxication including hypoactivity, tremor, convulsions, salivation, dyspnea, prostration within 4 hours post dosing
Gross pathology:
At autopsy , survivors showed no significant findings, decedents showed hemorrhage of gastrointestinal tract, hyperemia of liver , kidneys and lungs
Other findings:
no further data

All animals showed signs of intoxication including hypoactivity, tremor, convulsion, salivation, dyspnea, prostration within 4 hours post dosing and from 100 mg onwards animals died.
Mortality occurred within 4 hours post dosing;
68 mg/kg bw: no deaths but signs of intoxication; recovery within 2 days
100 mg/kg bw: mortality: 2/5; survivors recovered within 4 days
147 mg/kg bw: mortality: 3/5; surviors recovered within 6 days
215 mg/kg bw: mortality: 5/5

At autopsy, survivors showed no significant findings, decedents showed hemorrhage of gastrointestinal tract, hyperemia of liver, kidney and lungs.

Interpretation of results:
Category 3 based on GHS criteria
Executive summary:

To determine LD50 -value 5 male rats/dose received single oral doses of 68, 100, 147, 215 mg/kg bw by gavage and were observed for symptoms and mortality for up to 10 -14 days. Suvivors and decedents were examined afterwards by gross autopsy.

LD50 was determined 121 mg/kg bw (Industrial Bio-test Laboratories 1969).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
121 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: individual animal not shown
Principles of method if other than guideline:
5 rabbits/dose, exposure period not given, observation up to 14 days, gross autopsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no further data
Type of coverage:
not specified
Vehicle:
other: undiluted
Details on dermal exposure:
no further data
Duration of exposure:
no data
Doses:
681, 1000, 1470, 2150 mg/kg bw.
No. of animals per sex per dose:
5 rabbits/dose.
Control animals:
not specified
Details on study design:
no further data
Statistics:
yes, but method not mentioned
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 380 mg/kg bw
95% CL:
>= 841 - <= 2 260
Remarks on result:
other: clinical signs included hypoactivity salivation, tremors ; dermal irritation: severe erythema
Mortality:
681 mg/kg bw: 1/5
1000 mg/kg bw: 2/5
1470 mg/kg bw: 2/5
2150 mg/kg bw: 4/5
Clinical signs:
other: Hypoactivity salivation, tremors; dermal irritation: severe erythema.
Gross pathology:
Gross autopsy: survivors: no significant findings; decedents: hyperemia of the liver and lungs.
Other findings:
no further details

Signs of intoxication: Hypoactivity, salivation, tremor, severe erythema.

681 mg/kg bw: 1/5 rabbit died between day 8 and day 14, but showed no signs of intoxication.
1000 mg/kg bw: clinical signs developed between 4-12 hours and 2/5 rabbits died within the first 2 days.
1470 mg/kg bw: clinical clinical signs developed between 4-12 hours, 1/5 rabbit died on day 2 and 1/5 between day 8 and day 14.
2150 mg/kg bw: clinical signs developed between 0-4 hours, death of 4/5 rabbits occurred within 4 days.

Gross autopsy revealed in survivors no significant findings; decedents showed hyperemia of the liver and lungs.

Interpretation of results:
Category 4 based on GHS criteria
Executive summary:

Single dermal application of undiluted o-cresol (681 -2150 mg/kg bw) to the skin of rabbits resulted in an LD50 value of 1380 mg/kg bw. Clinical signs displayed by the animals included hypoactivity, tremors, convulsion, salivation, dyspnea, prostration and additionally severe erythema.(Industrial Biotest Laboratories 1969).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 380 mg/kg bw

Additional information

There is no study according to the current guideline but the given information is sufficient to evaluate this endpoint.

ORAL APPLICATION

To determine LD50 value 5 male rats/dose received single oral doses of 68, 100, 147, 215 mg/kg bw by gavage and were observed for symptoms and mortality for up to 10 -14 days. Suvivors and decedents were examined afterwards by gross autopsy: LD50 was determined 121 mg/kg bw (Industrial Bio-test Laboratories 1969).

DERMAL APPLICATION

Single dermal application of undiluted o-cresol (681 -2150 mg/kg bw) to the skin of rabbits resulted in an LD50 value of 1380 mg/kg bw . Clinical signs displayed by the animals included hypoactivity, tremor, convulsion, salivation, dyspnea, prostration and additionally severe erythema.(Industrial Biotest Laboratories 1969).

INHALATION EXPOSURE

No rat died during the 1 hour exposure against 1.22 mg/l. (not further specified, Ind Bio-test Lab Inc 1969). Following a 6 hour exposure of rats against o-cresol mist no animal died upto 20 mg/l. (Conoco Inc 1982). Clinical signs displayed by animals included hypoactivity, tremor, convulsion, salivation, dyspnea , prostration .In an early, not adequately documented publication, exposure of mice against o-cresol (mixture of vapour and aerosol) resulted in a LC50 value 0.178 mg/l but neither exposure time nor any other experimental details are given. Thus, the reliability of this information is not assignable (Uzhdanini 1972, 1974).

Overall, the data base on acute inhalation toxicity of o-cresol is very limited and does not allow final conclusion. Nevertheless further testing is not required because o-cresol is evaluated as corrosive and is classified /labelled accordingly. This is in accordance with the specific rules (Column 2) of ANNEX VIII No. 8.5 of Regulation (EC) No. 1907/2006 (REACH): Acute toxicity studies do not generally need to be conducted if the substance is classified as corrosive to the skin.

Justification for classification or non-classification

Under R67/548/EEC (19.ATP) m-and p-cresol as well as o-cresol ared classified as toxic in contact with skin and if swallowed R24/25

Referring to the acute inhalation exposure the given information is insufficient to evaluate the need for classification because important exeperimental datails are not given. Therefore no classification is required.

According to CLP classification criteria (Regulation (EC) No 1272/2008) the substance is allocated to category 3 for acute toxicity by oral and dermal route; Hazard Communication H301 and H311.