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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH/MAIN, FRG
- Weight at study initiation: 3.21 kg for male and 3.80 kg for females
- Housing: single in cage made of stainless steel with wire mesh walk floors. Floor area: 40 cm x 51 cm
- Diet: Kliba 341, 4MM; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day); ad libitum
- Water: about 250 ml tap water per animal per day; ad libitum
- Acclimation period: at least 8 day (clipping of the fur at least 15 hours before the beginning of the study)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20-24°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

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 ml
- Concentration (if solution): unchanged
Duration of treatment / exposure:
4 hour(s)
Observation period:
4, 24, 48 and 72 hours
Number of animals:
3 (one male 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: no data
- Type of wrap if used: test patches are secured in position with a porous dressing (4 layers of absorbent gauze + porous bandage).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure period

SCORING SYSTEM: OECD

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: a slight erythema (1) was observed in 2 animals 30-60 min after treatment, but resolved within 24 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
all irritation scores were 0 after 24, 48 and 72 hours
Other effects:
no other effects

Any other information on results incl. tables

No signs of irritation were observed in 2 additional groups for each 3 animals treated for 1 or 3 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met