Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 26, 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
Number of animals: 4 rabbits (2 male and 2 female)
GLP compliance:
no
Remarks:
Pre GLP.
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate
EC Number:
942-100-5
Molecular formula:
Not applicable: UVCB substance
IUPAC Name:
Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
other: New Zeland
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.94 - 3.2 g
- Housing: individually in suspende, wire - bottomed cagesand maintained on a standard laboratory ration
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- % coverage: 30%
- Type of wrap if used: plastic wraptaped in place

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h
Duration of exposure:
24 h
Doses:
2025 mg/kg bw
No. of animals per sex per dose:
2 male and 2 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Initial and final body weight recorded
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, behavioral abnormalities.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 025 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred
Clinical signs:
No untoward behavioral reactions were noted
Body weight:
Growth has been not influenced
Gross pathology:
No gross pathologic alterations revealed
Other findings:
A bright blue stain noted at the 24h, 7d and 14d observations

Any other information on results incl. tables

Mortality and body weight data:

dose
mg/kg bw
animal  individual body weight n° dead/
n°tested
% dead
sex day n° 0 day n° 14
2025 1 m 3.2 3.24 0/4 0
2 m 2.94 2.6
3 f 3.2 3.2
4 f 3.2 3.24

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 (male/female) > 2025 mg/kg bw
Executive summary:

The substance to be registered has been tested according a procedure similar to OECD 402, during the study the single dose 2025 mg/kg bw has been tested on 4 rabbits (2 male and 2 female). After the 14 days observation period there were no deaths , untoward behavioral reactions or adverse body weight effect. A bright blue stain was noted at the contact site at 24h, 7d, 14d observations. Necroscopy revealed no gross pathologic alterations among any animals. In these experimental conditions the test item shows a LD50 > 2025 mg/kg bw.

Categories Display