Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD TG 402 and EEC Directive 440/2008 Part B, Method B.3
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Dye content: 41.2 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-13 weeks
- Weight at study initiation: males: 269-276g; females: 233-256 g
- Fasting period before study:
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
2000 mg/kg bw was applied onto the shorn back of 5 male and 5 female rats and held in place by semi-occlusive dressing The treatment time was 24 hours. After removing of the dressing the treated area was rinsed. The animals were observed for clinical signs and mortality over a period of 14 days.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
2000 mg/kg bw was applied onto the shorn back of 5 male and 5 female rats and held in place by semi-occlusive dressing The treatment time was 24 hours. After removing of the dressing the treated area was rinsed. The animals were observed for clinical signs and mortality over a period of 14 days.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animal died, none showed any reaction on treatment
Mortality:
No animal died
Clinical signs:
No clinical signs were observed
Body weight:
Body weight development was not affected by treatment
Gross pathology:
No grosspathological findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Bayscript Blaukomponente (konserviert) was applied dermally to the shorn back and flank of groups of male and female Wistat rats at a dose of 2000 mg/kg bw under semi-occlusive conditions (OECD TG 402). After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxcolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50( rat, dermal) is > 2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

Bayscript Blaukomponente (konserviert) was applied dermally to the shorn back and flank of groups of male and female Wistat rats at a dose of 2000 mg/kg bw under semi-occlusive conditions (OECD TG 402). After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxcolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50( rat, dermal) is > 2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.