p-tolualdehyde

Endpoint summary

Description of key information

Acute oral toxicity: The LD50 value was determined to be 1000 mg/kg bw.

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Ten male ICR mice were exposed to the test substance via oral gavage. They were exposed to 0, 856, 916, 980, 1049, 1122 mg/kg bw. After 10 days the LD50 was determined. A second group of ten male ICR mice was exposed to 1000 mg/kg bw. Necropsy was performed on this second group on day 1 and day 18 on 5 animals per time point.

GLP compliance:

not specified

Test type:

standard acute method

Specific details on test material used for the study:

- purity: 99.3%
- Lot No.: 52.3.9

Species:

mouse

Strain:

ICR

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4 weeks
- Weight at study initiation: 25 ± 1 g
- Fasting period before study: overnight before study
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 55 ± 10

Route of administration:

oral: gavage

Vehicle:

other: 1% Tween 80

Doses:

- 1st study: 856, 916, 980, 1049, 1122 mg/kg bw
- 2nd study (necropsy): 1000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

yes

Remarks:

concurrent vehicle

Details on study design:

1st study:
- Duration of observation period following administration: 10 days
- Frequency weighing: animals were weighed on day 0, 3 and 10.

2nd study:
- Necropsy was performed on day 1 and 18 in the 2nd study on 5 animals per time point

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

Based on:

test mat.

95% CL:

>= 970 - <= 1 030

Mortality:

Mortality information 1st study:
- 0 out of 10 animals died exposed to 0 mg/kg bw
- 0 out of 10 animals died exposed to 856 mg/kg bw
- 1 out of 10 animals died exposed to 916 mg/kg bw
- 3 out of 10 animals died exposed to 980 mg/kg bw
- 8 out of 10 animals died exposed to 1049 mg/kg bw
- 10 out of 10 animals died exposed to 1122 mg/kg bw

Body weight:

Mean body weight (in g) on day 0, 3, 10 (measured in 1st study):
- 0 mg/kg bw: -, 23.5, 27.3
- 856 mg/kg bw: 25.4, 27.3, 26.8
- 916 mg/kg bw: 25.08, 23.2, 28.1
- 980 mg/kg bw: 24.72, 27.1, 25.7
- 1049 mg/kg bw: 24.21, 26.0, -

Gross pathology:

No abnormality was noted in animals exposed to 1000 mg/kg bw in the 2nd study

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

Ten male ICR mice were exposed to the test substance via oral gavage. They were exposed to 0, 856, 916, 980, 1049, 1122 mg/kg bw. After 10 days the LD50 was determined. A second group of ten male ICR mice was exposed to 1000 mg/kg bw. Necropsy was performed on this second group on day 1 and day 18 on 5 animals per time point. No abnormality was noted upon gross pathology. The LD50 was determined to be 1000 mg/kg bw.

Endpoint conclusion

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Ten male ICR mice were exposed to the test substance via oral gavage. They were exposed to 0, 856, 916, 980, 1049, 1122 mg/kg bw. After 10 days the LD50 was determined. A second group of ten male ICR mice was exposed to 1000 mg/kg bw. Necropsy was performed on this second group on day 1 and day 18 on 5 animals per time point. No abnormality was noted upon gross pathology. The LD50 was determined to be 1000 mg/kg bw.

Justification for classification or non-classification

Based on the findings of the study classification the substance needs to be classified as Xn, R22 (Harmful if swallowed) in accordance with Directive 67/548/EEC and as Acute Tox. 4, H302 (Harmful if swallowed) in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

As there are no studies available for acute inhalation and dermal toxicity classification for acute inhalation and dermal toxicity is not possible in accordance with Directive 67/548/EEC and in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.