Pyridine-2-carbaldehyde

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-08-16 to 2001-09-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

(The Department of Health of the Government of the United Kingdom)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pyridine-2-carbaldehyde

EC Number:

214-333-6

EC Name:

Pyridine-2-carbaldehyde

Cas Number:

1121-60-4

Molecular formula:

C6H5NO

IUPAC Name:

pyridine-2-carbaldehyde

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl: CD® (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation : approximately 8 weeks
- Weight at study initiation : at least 200g
- Fasting period before study : no
- Housing : The animals were housed in suspended polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet : Rat and Mouse SQC Expanded Diet No. 1 (Special Diets Services Limited, Witham, Essex, UK) , ad libitum
- Water : mains drinking water , ad libitum
- Acclimation period : at least 5 days

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure : a shorn area on the back and flank of the rats
- % coverage : 10%
- Type of wrap if used : selfadhesive semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing : the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure : 24 hours

TEST MATERIAL
- Amount(s) applied : Dose Level : 2000 mg/kg bw (Dose Volume : 1.80 ml/kg)
- Constant volume or concentration used : yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5; initially one male and one female rat were treated with the test material at a dose level of 2000 mg/kg. After evaluation of the reactions in these animals an additional group of four male
and four female animals were treated in a similar manner.

Control animals:

no

Details on study design:

- Duration of observation period following administration : 14 days
- Frequency of observations and weighing : The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days . After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation (according to the DRAIZE scoring system) . Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Skin Irritation :
Signs of dermal irritation noted during the study were light brown discolouration of the epidermis, crust formation, small superficial scattered scabs, possible green/brown-coloured dermal necrosis, hardened light brown coloured scab and scab lifting to reveal glossy skin . Adverse reactions prevented evaluation of erythema and oedema at one treated skin site seven to fourteen days after treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

according to CLP regulation not classified

Conclusions:

The study was performed according to the OECD TG402 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1).The validity criteria of the test system was fulfilled. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight. The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with the CLP regulation.

Executive summary:

The acute dermal toxicity of the test material was investigated in rats. The test was conducted according to OECD TG402 and EU Method B. 3. 2000 mg/kg bw of the test substance was applied semiocclusive to the shaved skin of rats. After 24 h the animals were unwrapped and observations were made for a period of 14 days. No mortalities occured during the study. There were no signs of systemic toxicity reported. Signs of dermal irritation noted during the study were light brown discolouration of the epidermis, crust formation, small superficial scattered scabs, possible green/brown-coloured dermal necrosis, hardened light brown coloured scab and scab lifting to reveal glossy skin. Adverse reactions prevented evaluation of erythema and oedema at one treated skin site seven to fourteen days after treatment. All animals showed expected gains in bodyweight over the study period except for one male animal which showed bodyweight loss over the second week. No abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with the CLP regulation.