Thiazol Blau

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 to 17 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: Thiazol Blau

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: 9 weeks, males: 7 weeks)
Body weight range at dosing: Between 222 g and 256 g
Acclimatization time: 14 days (females) 7 days (males)
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: Female Day [-14]
Male Day [-7]
Veterinary control: Female Day [-13]
Male Day [-6]
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:

blue discoloration of the fur surrounding treated skin or at axillary/thoracic area in four females

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 Thiazol Blau 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 Thiazol Blau 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 9 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).

 

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 Thiazol Blau, blue staining of the skin and fur was observed from Day 1 up to Day 10 and Day 14 in all animals, respectively.

 

Body weight

The body weight and body weight gain of Thiazol Blau treated animals did not show any test item-related effect.

 

Necropsy

At necropsy,blue discoloration of the fur surrounding the treated skin or at axillary/thoracic area was observed in four females.

 

Conclusions

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