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Diss Factsheets

Administrative data

Description of key information

The test substance induced severe necrosis of the rabbit skin after application during 3 minutes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12/04 1989 to 18/04 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: conform the guideline, non-GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: white russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Tomae GmbH Biberach
- Age at study initiation:
- Weight at study initiation: 2.3 kg
- Housing: individual
- Diet : K4 Alleindiät für Kaninchen, Ssniff Spezialfütter GmbH Soest, ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12 April 1989 To: 18 April 1989
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 cm3
Duration of treatment / exposure:
4 hours
Observation period:
scored at 1, 24, 48 and 72 hours and after 6 days
Number of animals:
1
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h and 6 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe necrosis at all timepoints, crusts from 48 h onwards
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h and 6 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
after exposure for 3 min severe necrosis was observed after 1 hour
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
The test substance is considered corrosive to the skin
Executive summary:

Dermal application of the test substance to rabbits resulted in severe necrosis after 3 minutes or 4 hours exposure. The test substance is considered corrosive to the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
only study available on the test substance

Justification for selection of eye irritation endpoint:
study waived based on the outcome of the in vivo skin irritation test which showed that the test substance is corrosive 1A

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

The substance needs to be classified as Corrosive 1A H314: Causes severe skin burns and eye damage