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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:
1987-11-09 to 1987-11-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: - Guideline study with acceptable restrictions (e.g. deviations from the guideline concerning exposure time and amount of supplied test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
only 1 day of acclimatisation time, 24 h exposure time and only 0.3 g substance applied; in addition a repeated dose experiment was conducted
Principles of method if other than guideline:
repeated dose experiment:
4 animals per dose group were treated daily for 10 consecutive days by spreading the inner areas of the right ear with a suspension (2 % or 10 % (w/v)) of the test substance in the vehicle.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house breeding facility
- Age at study initiation: 28 - 38 weeks
- Weight at study initiation: 3.6 - 4.0 kg
- Housing: 1 per cage (stainless steel cages with grating floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 day


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 +- 1
- Humidity (%): 55 +- 10
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: one site intact and shaved, one site shaved and abraded
Vehicle:
other: polyethylene glycol (PEG 400)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 300 mg moistened sufficiently with polyethylene glycol.



Duration of treatment / exposure:
- 24 h in the experiment according to the guideline
(- daily for 10 days in the repeated dose experiment)
Observation period:
- 28 days
(- 10 days in the repeated dose experiment)
Number of animals:
- 6
(- 4 per dose in the repeated dose experiment)
Details on study design:
TEST SITE
- Area of exposure: flank between shoulder and sacral region
- coverage: 2.5 cm x 2.5 cm, linen cloth
- Type of wrap if used: bandage, wrapped several times around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 24 h

SCORING SYSTEM:
(Draize, J. H. (1977) „Dermal and Eye Toxicity Tests“. Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC, p. 31)


Erythema and Eschar Formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation
injuries in depth 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond
the area of exposure 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean of all animals
Time point:
other: mean of 1, 24 and 48 h
Score:
3.25
Max. score:
4
Reversibility:
fully reversible within: 12 d
Remarks on result:
other: no reading was conducted at 72 h; values given as 3- 4 were calculated as 3.5
Irritation parameter:
edema score
Basis:
other: mean of all animals
Time point:
other: mean of 1, 24 and 48 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: no reading was conducted at 72 h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.5
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.25
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.25
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h; values given as 3-4 were calculated as 3.5
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3.75
Max. score:
4
Reversibility:
fully reversible within: 12 d
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h; values given as 3-4 were calculated as 3.5
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.75
Max. score:
4
Reversibility:
fully reversible within: 12 d
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema determined at any time point
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema determined at any time point
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema determined at any time point
Remarks on result:
other: no reading was conducted at 72 h; score represents mean value of 24 and 48 h
Irritant / corrosive response data:
- see table 1
Other effects:
- in all animals: erythema, oedema, erosions, pachydermatosis and necrosis
- At the application site eschar formation and desquamation of the epidermis were observed from the 5th day after compound application; thereafter scar was formed. Full recovery with fur covering scar area was observed between day 25 and 29.
There were no significant difference between unabraded and abraded skin reaction.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Under the conditions of this skin irritation study an average edema score of 0.33 and an average erythema score of 3.25 were deduced (average of all animals, time points: 1, 24, 48 h). No deaths occurred during the study period and no signs of toxicity were reported. Based on the results it can be concluded that the test substance has corrosive effects on the skin of rabbits.