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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Details on the read across are reported in section 13. Source study has reliability 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Acid Yellow 049 acid
IUPAC Name:
Acid Yellow 049 acid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Spolkem chovatelů z Hradce Králové.
- Weight at study initiation: 2.5 kg.
- Housing: housed individually in metal cages.
- Diet: pelleted standard commercially manufactured compound KO-16, supplied by s.p. Velaz Prague.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 50 ± 15 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: scarified and intact shaved skin
Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Application: as aqueous paste.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three rabbits
Details on study design:
TEST SITE
- Area of exposure: a day before the application, experimental rabbits were depilated on the left and right lateral surface (area 6 × 6) of the abdominal area; the skin of the right side was scarified.
- Type of wrap if used: gauze was covered by aluminum foil and cellulose wadding. Bandage was fixed by technical tape.

OBSERVATION TIME POINTS
Dermatological skin diagnostics was perfromed focusing on the symptoms of erythema, edema at 4, 24, 48 and 72 hours. The degree of erythema was diagnosed by visual check and palpation. Additional clinical examination was carried out at 24, 48 and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Reversibility:
fully reversible within: 24 hrs
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Reversibility:
fully reversible within: 24 hrs
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Animal no.

Reaction

After 4 hrs After 24 hrs After 48 hrs After 72 hrs
Intact skin Scarified skin Intact skin Scarified skin Intact skin Scarified skin Intact skin Scarified skin
22 Erythema 0 0 0 0 0 0 0 0
28 Erythema 0 1 0 0 0 0 0 0
29 Erythema 0 0 0 0 0 0 0 0
22 Oedema 0 1 0 0 0 0 0 0
28 Oedema 0 0 0 0 0 0 0 0
29 Oedema 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritating to rabbit skin.
Executive summary:

Method

The skin irritation potential of the substance was determined following OECD guideline 404. 0.5 g of test substance were placed on both intact and scarified skin, as aqueous paste. Three rabbits were used.

After 24 hours of exposure the bendage was removed and the reactions scored.

Result

The primary irritation score was 0.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema and oedema reactions (in both intact and scarified skin).