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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
30 July 1998 - 07 August 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ARAKAWA KE-604
- Physical state: pale yellow blocks
- Analytical purity: no data
- Lot/batch No.: R61132
- Storage condition of test material: room temperature in the dark.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.75 - 2.80 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): mains drinking water
- Water (e.g. ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 65-74
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

EXPERIMENTAL DATES: The study was performed between 30 July 1998 and 07 August 1998

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping using a veterinary clipper
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL of distilled water
Duration of treatment / exposure:
Initially treated rabbit: 3 minutes, 1 hour and 4 hours.
2nd and 3rd rabbit: 4 hours.
Observation period:
72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal flank area
- % coverage: 6.25 cm2
- Type of wrap if used:
The cotton gauze patch was held in position with a strip of surgical adhesive tape (BLENDERM).
The trunk of the animal was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 minutes, 1 h, 4 h.

SCORING SYSTEM: According to Draize J H, 1977, "Dermal and Eye Toxicity Tests" in : Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p. 31.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean of
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Other effects:
No other effects noted.

Any other information on results incl. tables

Table 1: Individual skin examination scores after 4h-exposure

Skin effect

Erythema

Edema

Scoring [h]a

1

24

48

72

Meanb

1

24

48

72

Meanb

Animal No. /sex

#1 / m

1

0

0

0

0.0

1

0

0

0

0.0

#2 / m

0

0

0

0

0.0

0

0

0

0

0.0

#3 / m

1

0

0

0

0.0

0

0

0

0

0.0

aTimepoint of reading after substance removal subsequent to 4h-dermal exposure

bMean of 24, 48 and 72 h scores

Summary:

In a primary dermal irritation study, the skin irritation/corrosion potential of ARAKAWA KE-604 was tested. The clipped dorsal flank area of 3 male New Zealand White rabbits was exposed for 4 hours to 0.5 g of the test substance moistened with 0.5 mL of distilled water under semi-occlusive conditions. The rabbits were observed for 72 hours. Skin reactions were assessed according to Draize scheme 1, 24, 48 and 72 hours after removal of the test substance. No oedema and no erythema was noted at the 24, 48 and 72 hour observation intervals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information No classification is needed according to EU classification criteria. Criteria used for interpretation of results: EU