Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 October - 12 November 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test was performed in accordance with OECD, but not according to GLP guidelines and the English test report was reconstructed by the test institute from the study raw data and the original Czech report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding Farm VELAZ, monitoring quality
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 225-275 g
- Fasting period before study: not stated
- Housing: 5 animals per plastic breeding cage VELAZ T4
- Diet (e.g. ad libitum): ST 1 Bergman - standard pellet diet ad libitum, Mill Kocanda, Jesenice u Prahy, Czech Republic
- Water (e.g. ad libitum): dinking tap water ad libitum
- Acclimation period: minumum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 3°C (air-condition)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 4x6 cm (shaved 24 hours before application)
- Type of wrap if used: application site was covered by mull, plastic foil and held in contact by plaster (strapping)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24-hour application period, the remains of the test substance were removed from the skin
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): water was used to moisten test substance
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical examination was done after 30 min, 3 hours of the 1st day, in the moring and afternoon of the second day and thereafter daily for 14 days; body weights were recorded before application, atday 8 and before euthanasia of animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight:
Statistics:
not relevant

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
All animals survived the 14-day observation period.
Clinical signs:
No clinical signs were observed during the 14-day observation period.
Body weight:
Body weight developments were within the physiological range.
Gross pathology:
All animals were without gross morphological alterations.
Other findings:
none

Applicant's summary and conclusion

Conclusions:
67/548/EEC: Acute oral toxicity: no classification warranted
1272/2008/EC: Acute oral toxicity: no classification warranted

The Test item (<90% Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight.