Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: Thiazol Blau

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
no clinical signs were observed
Body weight:
no test item related effects
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.