2,4,6-trimethylbenzaldehyde

Endpoint summary

Description of key information

The acute oral LD50 of the test material in the Sprague-Dawley rat was >2000 mg/kg body weight (OECD 401).

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 118 ± 3.1 g (males) and 94.9 ± 2.6 g (females)
- Fasting period before study: overnight
- Housing: Six to 10 animals were housed per cage (suspended metallic cages for rats) and reared on rat cage racks with automatic water supply syste.
- Diet: pellet food for rats MF (Oriental Yeast Co., Ltd.), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 55 ± 6
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.25, 0.5, 2, 5 and 20 (w/v)%

MAXIMUM DOSE VOLUME APPLIED: 1.0 mL/100 g

Doses:

25, 50, 200, 500 and 2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: General signs and symptoms: every day. Animals were weighed on Day 0 (day of administration), immediately before administration, and on Days 2, 7 and 14
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No male or female from any of the five groups died during the study period.

Clinical signs:

other: In the 25, 50, 200 and 500 mg/kg groups, no male showed any abnormality, while in the 2,000 mg/kg group, body drooping began to be seen about 20 min after administration. All six males in this group showed this change thereafter together with sedation. In

Gross pathology:

Necropsy conducted at the end of the study period in all surviving males and females from the 25, 50, 200, 500 and 2,000 mg/kg groups revealed no abnormality.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was estimated to be >2000 mg/kg bw in both males and females.

Executive summary:

In an acute oral toxicity study, performed according to OECD guideline 401, groups of 6 fasted Sprague-Dawley CD rats per sex per dose were treated once with the test substance at 0, 25, 50, 200, 500 and 2000 mg/kg dissolved in olive oil by oral gavage followed by a 14 -day observation period.All animals survived. In the 25, 50, 200 and 500 mg/kg groups, no abnormalities were observed. Signs of systemic toxicity noted during the study in the 2000 mg/kg bw dose group included body drooping, sedation, staggering, lacrimation, collapse, decrease in spontaneous locomotion, and slowing of breathing. Animals were without symptoms within 3 days. All animals showed expected gains in bodyweight over the study period, and no abnormalities were noted at necropsy. In conclusion, the acute oral LD50 of the test substance in Sprague-Dawley rat was estimated to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

OECD guideline study, klimisch 1

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

In an acute oral toxicity study, performed according to OECD guideline 401, groups of 6 fasted Sprague-Dawley CD rats per sex per dose were treated once with the test substance at 0, 25, 50, 200, 500 and 2000 mg/kg dissolved in olive oil by oral gavage followed by a 14 -day observation period. All animals survived. In the 25, 50, 200 and 500 mg/kg groups, no abnormalities were observed. Signs of systemic toxicity noted during the study in the 2000 mg/kg bw dose group included body drooping, sedation, staggering, lacrimation, collapse, decrease in spontaneous locomotion, and slowing of breathing. Animals were without symptoms within 3 days. All animals showed expected gains in bodyweight over the study period, and no abnormalities were noted at necropsy. In conclusion, the acute oral LD50 of the test substance in Sprague-Dawley rat was estimated to be greater than 2000 mg/kg bodyweight.

Justification for selection of acute toxicity – oral endpoint
Only study available, OECD guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Justification for classification or non-classification

Based on the findings of the oral acute toxicity study, classification for acute oral toxicity is not warranted according to Directive 67/548/EEC and according toEU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.