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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 July - 15 July 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed in accordance with OECD and GLP guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 2 months to 5 months
- Weight at study initiation: 3.0 kg to 3.9 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2013) ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 2°C (air-condition)
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Polyethyleneglycol 400
Controls:
not required
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): 0.3 ml PEG 400 to moisten the test item
- Lot/batch no. (if required): not stated
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was cautiously removed
- Time after start of exposure: 4 hours

SCORING SYSTEM:
as described by Draize [identical to EU Method B.4] assessed approximately 30 - 60 min, 24, 48, and 72 h after the romoval of the test item

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: erythema grade 0 - 0 -1 observed in the three animals at 30-60 min reading were fully reversible within 24 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: erythema grade 0 - 0 - 1 observed in the three animals at 30-60 min reading were fully reversible within 24 hours
Irritant / corrosive response data:
Scores (oedema or erythema) were 0 at 24, 48 and 72 h after removal of dressing in all animals.
Other effects:
Weak pink staining produced by the test item was present at the 30-60-minute and the 24-hour readings.

Applicant's summary and conclusion

Conclusions:
67/548/EEC: Skin irritation: no classification warranted
1272/2008/EC: Skin irritation: no classification warranted

In a OECD guideline and GLP compliant primary skin irritation test in rabbits, the test item (Pigment Red 112) caused grade 0-1 erythema and edema after 30-60 minutes, while neither erythema nor edema were observed 24, 48 and 72 hours after application of the test substance. Therefore, the test item (Pigment Red 112) was regarded as not skin irritating.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema. These effects were reversible and were no longer evident 24 hours after treatment for all animals. Staining of the treated skin was noted in all animals until the 24 -hour reading. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant irritative or irreversible damage to the skin. Therefore, Permanent-Rot FGR 02 is considered to be "not irritating" to rabbit skin.