Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
26 to 29 May 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to OECD 404 and GLP guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
Name: Golden Yellow Continuous

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Species and strain: New Zealand White rabbit
- Source: Sándor Ferenc, 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: 9 weeks
- Weight at study initiation: 3455 to 3694 g
- Housing: single
- Diet: PURINA Base – Lap gr. diet for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: 27 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.7 to 21.7
- Humidity (%): 31 to 72
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 26 to 29 May 2009

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
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
- Type of wrap if used: plastic wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): body temperature water
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Erythema and eschar formation

No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exp.) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1, 2, 3
Time point:
other: 24 to 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
1,2,3
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
At observation one and 24 hours after patch removal, very slight erythema (score 1) was found in all animals.
At 48 and 72 hours after patch removal, there were no signs of skin irritation observed.
As no local or systemic clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72-hour observation.
The animals’ individual mean scores considering readings at 24, 48 and 72 hours after patch removal for erythema were 0.33, 0.33 and 0.33, respectively.
The animals’ individual mean scores considering readings at 24, 48 and 72 hours after patch removal for oedema were 0.00, 0.00 and 0.00, respectively.
Other effects:
no mortality, clinical signs of effects on body weights

Any other information on results incl. tables

SCORING OF ERYTHEMA FORMATION

 

Animal No./
Sex

Body weight (g)

1 h

24 h

48 h

72 h

at the beginning
of the study

at the end
of the study

04095/ M

3681

3771

1

1

0

0

04098/ M

3455

3529

1

1

0

0

00043/ M

3694

3827

1

1

0

0

TOTAL

-

-

3

3

0

0

  

 

SCORING OF OEDEMA FORMATION

 

Animal No./
Sex

Body weight (g)

1 h

24 h

48 h

72 h

at the beginning
of the study

at the end
of the study

04095/ M

3681

3771

0

0

0

0

04098/ M

3455

3529

0

0

0

0

00043/ M

3694

3827

0

0

0

0

TOTAL

-

-

0

0

0

0

M = male; d = day; h = hour

 

 

  

MEAN VALUES OF SKIN IRRITATION SCORES

(24, 48, 72 hours reading)

  

Animal Number

Sex

Erythema

Oedema

04095

male

0.33

0.00

04098

male

0.33

0.00

00043

male

0.33

0.00

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to Directive 2001/59/EC and Regulation (EC) No 1272/2008, Golden Yellow Continuous does not require classification as a skin irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Golden Yellow Continuous does not require classification as a skin irritant.
Executive summary:

An acute skin irritation study of the test item Golden Yellow Continuous was performed in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 404, 2002).

An amount of 0.5 g of the solid test item was applied neat to the skin of the experimental animals. The test item was applied as a single dose. Sufficient water to damp the material was used to ensure good contact with the skin and an adhesive clear plastic patch was applied. The trunk was wrapped in a semi-occlusive clear plastic film with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.

After 4 hours, the remaining test item was removed with water of body temperature.

To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily.

 

There was no mortality or systemic clinical change related to Golden Yellow Continuous administration.

There was no effect of treatment on body weight.

At observation one and 24 hours after patch removal, very slight erythema (score 1) was found at the application site in all animals.

At 48 and 72 hours after patch removal, there were no signs of skin irritation observed.

As no systemic or local clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72-hour observation.

 

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.33 at all time points.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00 at all time points.

 

According to Directive 2001/59/EC and Regulation (EC) No 1272/2008, Golden Yellow Continuous does not require classification as a skin irritant.

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Golden Yellow Continuous does not require classification as a skin irritant.