3,4-dimethylbenzaldehyde

Endpoint summary

Description of key information

The acute oral LD50 of the test material in the female Sprague-Dawley rat was >2000 mg/kg body weight (OECD 423, GLP).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Remarks:

Safepharm Laboratories Ltd., Shardlow Business Park, Shardlow, Derbyshire, DE72 2GD, UK

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 200-208 g
- Fasting period before study: yes, overnight
- Housing: The animals were housed in groups of three is suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by BCN IPS Limited, London, UK), ad libitumwith the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing
- Water: ad libitum with the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): ≥15
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.98 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

A group of 3 females, followed by a further group of 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Body weights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: yes

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths

Clinical signs:

other: Signs of systemic toxicity noted in all animals during the day of dosing were hunched posture, lethargy and ataxia. Hunched posture was noted in four animals and ataxia noted in three animals one day after dosing. Animals appeared normal one or two days a

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

In a GLP compliant acute oral toxicity study, performed according to OECD guideline 423, a group of 3 fasted female Sprague-Dawley CD rats were treated once with the test substance (2000 mg/kg bw) by oral gavage followed by a 14 -day observation period. This was followed by a further group of 3 fasted females treated once at the same dose level. All animals survived. Signs of systemic toxicity noted during the study were hunched posture, lethargy and ataxia. Animals appeared normal one or two days after dosing. 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 the female 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:

GLP-compliant 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 a GLP compliant acute oral toxicity study, performed according to OECD guideline 423, a group of 3 fasted female Sprague-Dawley CD rats were treated once with the test substance (2000 mg/kg bw) by oral gavage followed by a 14 -day observation period (Safepharm Laboratories Ltd.). This was followed by a further group of 3 fasted females treated once at the same dose level. All animals survived. Signs of systemic toxicity noted during the study were hunched posture, lethargy and ataxia. Animals appeared normal one or two days after dosing. 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 the female Sprague-Dawley rat was estimated to be greater than 2000 mg/kg bodyweight.

Justification for selection of acute toxicity – oral endpoint
Only study available, GLP compliant 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 to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.