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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-03-18 to 2008-05-29
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
first addendum
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
IUPAC Name:
Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
Constituent 2
Reference substance name:
Acid Yellow 42: 6375-55-9
IUPAC Name:
Acid Yellow 42: 6375-55-9
Constituent 3
Reference substance name:
Acid Black 2: reaction product of 8005-03-6 and 68510-98-5
IUPAC Name:
Acid Black 2: reaction product of 8005-03-6 and 68510-98-5
Constituent 4
Reference substance name:
Basic Violet 1: 8004-87-3
IUPAC Name:
Basic Violet 1: 8004-87-3
Details on test material:
- Name of test material: Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Lot/batch No.: 2008041541
- Expiration date of the lot/batch: 2010-01-31
- Stability under test conditions: see expiry date
- Storage condition of test material: store cool and dry
- Analytical purity: 100 % (96.8 %; UVCB substance)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc. TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats
- Weight at study initiation: Male: 256 - 270 g
Female: 213 – 230 g
- Housing: Individual caging (1 animal/cage)
- Diet (e.g. ad libitum): Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced
by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum
- Water (e.g. ad libitum): tap water from the municipal supply, ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): 8-12 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: total body surface
- % coverage: approximately 10 % of the total body surface
- Type of wrap if used: semi occlusive plastic wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed using water at body temperature.



Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality during the time of the study.
Clinical signs:
other: There were no clinical signs. The behaviour and physical condition of animals were considered to be normal.
Gross pathology:
No macroscopic alterations due to the effects of the test item were found

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the study the test substance revealed no toxic effects via the dermal route to rats. The LD0 was 2000 mg/kg bw and the LD50 > 2000 mg/kg.
Executive summary:

Based on a study according to EU method B.2 and OECD 402, a single dermal administration of the test item F 46 Black up to the limit concentration did not reveal any toxic effects in rats. The LD0 was 2000 mg/kg bw and the LD50 > 2000 mg/kg bw.