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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 13 - 25, 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Color/form: Yellow powder
Chemical family: azo pigment
Storage conditions: ambient temperature (15-30°C)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Canada, Montreal, Quebec
- Strain: New Zealand Albino (Crl:KBL(NZW)BR)
- Age at study initiation: approx. 20 weeks
- Weight at study initiation: 3.3-3.4 kg
- Housing: individual stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 (target range)
- Humidity (%): 30-70 (target range)
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: closely clipped free of hair
Vehicle:
other: moistening with Mineral Oil USP
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): the test article was moistened with Mineral Oil USP before applying it onto a gauze patch
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100%
- Type of wrap if used: the gauze patch was attached to the skin and loosely held in contact by using a 10x2.5 cm strip of adhesive tape. The whole trunk of the rabbit was then wrapped in a rubber dam and secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with Mineral Oil USP
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
No signs of irritation (erythema or oedema) were observed following the exposure period.
Other effects:
None observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The irritating potential of the test article was found to be negligible in accordance with the Dermal Classification System (OECD 404) used.