Pigment Yellow 214

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 31 AUG 1999 to 21 SEP 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 FEB 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

31 JUL 1992

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Details on test material:

Batch: V.N0199.064
Expiry: 09.07.2001

Test animals

Species:

rat

Strain:

other: HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: females 12 weeks, males 9 weeks
- Weight at study initiation: females between 186.1 and 208.6 g, males between 207.0 and 255.5 g
- Fasting period before study: no
- Housing: during treatment and observationindividually in Makrolon type 3 cageswith standard soft bedding
- Diet: pelleted standard Kliba 24-3433-4, batch no. 39/99 rat maintainace diet, ad libitum
- Water: Community tap water, ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: 10

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6.0 mL/ kg bw
- Concentration (if solution): 33% [w/v]
- Constant volume or concentration used: yes
- For solids, paste formed: no

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations four times during test day 1 and once daily during days 2-15, weighing on test day 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic findings

Statistics:

No statistical analysis was used as no deaths ocurred.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: exact LD50 not determinable due to absence of adverse toxic effect, no indication of skin irritation up to the relevant limit dose level.

Mortality:

No deaths ocurred during the study.

Clinical signs:

Yellow staining and test article remnants on the application site were observed. Yellow staining persisted in two males and three females until day 13.

Body weight:

Body weights were within the range commonly recorded for animals of this strain and age.

Gross pathology:

No macroscopic findings were observed at necroscopy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Single dermal application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in 5 male and 5 female HanIbm: WIST rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

Executive summary:

5 Male and 5 female rats (HanIbm: WIST) were subjected to test acute dermal toxicity according to the acute dermal toxicity test method (OECD TG 402, limit test). The test substance was applied semiocclusively to the animals backs at the limit dose of 2000 mg/kg bw in propylene glycol. After 24 h the test substnce was removed, the skin was washed clean and the animals were observed for 14 days. No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw. No skin irritation was observed either.