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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:
1990-02-20 - 1990-03-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Adequately performed and reported study following OECD 404 guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 100%
Appearance: yellow liquid
odour: amine like
Density: approx. 1 g/cm3
pH (at 20 ℃): approx. 11
melting point: approx. -14℃
Flash-point: approx. 218℃
Production data: 21.08.89
Batch: 2

Test animals

Species:
rabbit
Strain:
other: small white Russian, Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- number of animals: 3
- Marking: ear tattoo
- sex: male
- Age at study initiation: no data
- Weight at study initiation: 2,3-2,4 kg
- Housing: indiidual in steelcage
- Diet (e.g. ad libitum): ad libitum. K4 whole rabbit feed from Ssniff Spezialfutter GmbH, 4770 Soest.
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 14 days

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

IN-LIFE DATES: From: 20.02.1990 To: 01.03.1990

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 cm3
VEHICLE: no
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
4 h exposure: 48 hour (and then terminated)
1 h exposure: 72 hour (and then terminated)
3 minutes exposure: up to 8 days.
Number of animals:
3 animals, one for each exposure period.
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): careful rinsing with warm water.
- Time after start of exposure: 4 hr, 1 hr and 3 minutes respectively

SCORING SYSTEM:
As liste in OECD guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Exposure of 0,5 ml resulted to necrosis in following exposure duration of 4 hr, 1 hr and 3 minutes respectively

Any other information on results incl. tables

Results:

Animal exposure observation time
    1 hour 24 hours 48 hours 72 hours 6 days 8 days
    E O E O E O E O E O E O
1 4 hr x4 4 *N4 4 *N4 4          
2 1 hr 2 2 *N4 4 *N4 4 *N4 4      
3 3 min 2 2 *N4 4 *N4 4 *N4 4

*N4

Scp

4

*N4

Scpribl

4

E= erythema; O = Oedema

x = red/brown colouring of the application surface

* = red/brown colouring of the application surface, elevated crust, anemic (white) soft edge around crust.

N = Necrose

Scp = Crust

ri = fissures

bl = bloody

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Corrosive following 3 minute application to the skin after 24 hours but not at 1 hour.
Executive summary:

Exposure of the rabbit skin to 0,5 ml of undiluted test substance in acordance to OECD 0404 method, resulted to strong erythem and oedema and after 24 hours necrosis and development of crusts. There was no evidence of corrosion at the 1 hour observation time.