Polyamide wax

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2000-03-23 to 2000-08-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan U.K.
- Age at study initiation: 8 to 11 weeks of age
- Weight at study initiation: 210 to 257 g
- Fasting period before study: No
- Housing: Individually in metal cages fitted with grid floors
- Diet (e.g. ad libitum): Standard laboratory rodent diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21.5°C
- Humidity (%): 36 - 60% relative humidity
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0600 - 1800 hours GMT) in each 24-hour period

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: 1% w/v aqueous methylcellulose

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: waterproof dressing


REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with warm water


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4.0 ml/kg bw
- Concentration (if solution): 500 mg/ml
- Constant volume or concentration used: yes


VEHICLE
- Concentration (if solution): 1% w/v aqueous methylcellulose
- Lot/batch no. (if required): no data
- Purity: no data

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Ten Sprague-Dawley rats (five males and five females).

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: soon after dosing and on two occasions during the day (the day of study termination : only the morning)
- Frequency of weighing: on days 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured in any animal throughout the study.

Clinical signs:

other: There were no evidence of a systemic response in any animal throughout the study.

Gross pathology:

No macroscopic abnormalities were observed for animals killed at study termination.

Other findings:

- Other observations:
Slight irritation (erythema with oedema up to grade 1) was notable in seven rats following removal of the dressings on Day 2. In the majority of instances, the skin irritation had resolved by Day 4, however, in two animals slight irritation persisted before finally resolving in both instances by either Day 6 or Day 11. In two animals, a localised response (spots/scabbing) was first notable from Day 5 and persisted in one animal through to study termination (Day 15).

Any other information on results incl. tables

Table 7.2.2/1: Number of animals dead and number with evident toxicity

Dose (mg/kg bw)	Conc. in vehicle	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity(#/total)
		Male	Female	Combined		Male	Female	Combined
2000	500 mg/ml	0	0	0	0	0	0	0

Mean erythema score for all animals:

at 24 hours: 0.7

at 48 hours: 0.4

at 72 hours: 0.2

Mean oedema score for all animals:

at 24 hours: 0.7

at 48 hours: 0

at 72 hours: 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of the test substance was higher than 2000 mg/kg bw in rats.
Therefore, the substance is not classified according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.

Executive summary:

The substance was tested for acute dermal toxicity study according to OECD 402 guideline and in compliance with Good Laboratory Practices. A group of ten rats (five males and five females) received a single topical application of the test substance formulated in 1% w/v aqueous methylcellulose and administered at a dosage of 2000 mg/kg bw. The application site was covered by a semi-occlusive dressing for 24 hours. Skin was washed with water at the end of the 24 -hour exposure period.

Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period.

On completion of the observation period, the animals were sacrificed and then submitted to a macroscopic post-mortem examination.

No unscheduled deaths occurred during the study and no clinical signs were observed in any animals. Body weight was not affected by the treatment.

Slight irritation was notable in seven rats following removal of the dressings on Day 2. In the majority of instances, the skin irritation resolved by Day 4 excepted in two animals where slight irritation persisted up to Day 5 or Day 10. In two animals, localized response (spots/scabbing) was first notable from Day 5 and persisted up to the study termination on Day 15 for one animal.

At necropsy, there were no macroscopic findings related to the test item administration.

The acute dermal LD50 was found greater than 2000 mg/kg bw.