Golden Yellow Continuous

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 May 2009 to 09 June 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to OECD 402 and GLP guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Name: Golden Yellow Continuous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species and strain: CRL:(WI)BR Wistar rats
Source: CHARLES RIVER (EUROPE) LABORATORIES INC. TOXI-COOP Ltd. 1103 Budapest, Cserkesz u. 90.
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Justification of strain: The Wistar rat as a rodent is one of the standard species of acute toxicity studies
Number of animals: 5 animals/sex
Sex: Male and female, female rats were nulliparous and non-pregnant.
Age of animals: Young adult rats (females: 8 weeks, males: 7 weeks)
Body weight range at dosing: Between 215 g and 300 g
Acclimatization time: 6 days
Housing: Individual caging
Cage type: Type II. polypropylene/polycarbonate
Bedding: Laboratory bedding – Brandenburg Holzfaserstoffe Gmbh & Co.KG, Arkeburger Str. 31, 49424 Goldenstedt
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.9-24.6 °C
Relative humidity: 40-66 %
Ventilation: 15-20 air exchanges/hour
Enrichment: Rodents are housed with deep wood sawdust bedding to allow digging and other normal rodent activities.
Food: ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" ad libitum
Water: tap water ad libitum

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: 10 % area of the total body surface
- Type of wrap if used: semi occlusive plastic wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): water of body temperature
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

PRE-EXPERIMENTAL PERIOD
Animal receipt: Day [-6]
Veterinary control: Day [-5] to Day [-1]
Animal identification: Day [-1]

TREATMENT PERIOD
The day of treatment: Day 0
Body weight measurement: Day 0, 3, 7, 14
Clinical observation: 1 and 5 hours after treatment, then daily for at least 14 days
Necropsy: Day 14

Statistics:

NA

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: no clinical signs were observed

Gross pathology:

no test item related findings

Other findings:

OBSERVATION OF LOCAL DERMAL SIGNS

Red staining of the skin and hair was observed in all animals starting on Day 1, lasting up to Day 8. This staining attenuated to red staining of the hair in three males (Nos.: 4179, 4181 and 4182) and two females (Nos.: 4197 and 4198) and was noted up to Day 12.

Any other information on results incl. tables

	Male	Female
Dose (mg/kg bw)	2000	2000
Number of animals treated:	5	5
Mortality:	0/5	0/5

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of the test item Golden Yellow Continuous was found to be higher than 2000 mg/kg body weight in male and female CRL:(WI)BR rats.

Executive summary:

An acute dermal toxicity study was performed with test item Golden Yellow Continuous in CRL:(WI)BR rats, in compliance with OECD Guideline No.: 402.

A limit test was carried out at 2000 mg/kg body weight in both sexes (5 rats/sex; 7 to 8 weeks of age). The test item was applied as supplied, moistened with distilled water, as a single dermal 24-hour exposure followed by a 14‑day observation period.

Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 3, 7, and 14 thereafter.Rats were euthanized and necropsied at the end of the 2-week observation period (Day 14).

 

The results of the study were summarized as follows:

 

Mortality

No mortality occurred.

 

Observations of systemic clinical signs

No clinical signs were observed after the treatment with the test item or during the 14‑day observation period.

 

Observation of local dermal signs

After treatment with Golden Yellow Continuous, red staining of the skin and hair was observed up to Day 8 in all animals. Red staining of the hair was observed up to Day 12.

 

Body weight 

The body weight and body weight gain of Golden Yellow Continuous treated animals did not show any test item-related effect.

 

Necropsy

There were no test item-related macroscopic findings observed at necropsy.

Conclusions

The acute dermal median lethal dose (LD₅₀) of the test item Golden Yellow Continuouswas found to be higher than 2000 mg/kg bw in male and female CRL:(WI)BR rats.