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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:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSA
Principles of method if other than guideline:
24 hour exposure period on abraded and intact skin. Treated sites examined for reaction to treatment 24 and 72 hours following exposure.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): TK 10 496

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: In-house breeding
- Age at study initiation: 12 - 15 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: Individually caged
- Diet (e.g. ad libitum): Styles-Oxoid commercial rabbit diet, ad libitum
- Water (e.g. ad libitum): Sterile filtered water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 deg C
- Humidity (%): 50 - 70%
- Photoperiod (hrs dark / hrs light): 10 hours light / 14 hours dark cycle

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 50% (aq) polyethylene glycol
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 mL (500 mg test substance)
- Concentration (if solution): 10 g test substance mixed with 11 mL 50% (aq) polyethylene glycol
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours an 6 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Test sites: One abraded, one intact site / animal
- Type of wrap if used: Gauze pad covered with aluminium foil held in place by self adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - observations at 24 and 72 hours only

Any other information on results incl. tables

Intact skin

Animal No.

Erythema

Oedema

24 hours

72 hours

24 hours

72 hours

11 M

0

0

1

0

13 M

0

0

0

0

15 M

0

0

1

0

12 F

0

0

2

0

14 F

0

0

0

0

16 F

0

0

0

0

Mean

0.0

0.33

 

Abraded skin

Animal No.

Erythema

Oedema

24 hours

72 hours

24 hours

72 hours

11 M

1

0

2

1

13 M

1

0

0

0

15 M

1

0

1

0

12 F

0

0

2

0

14 F

1

0

0

0

16 F

1

0

1

0

Mean

0.42

0.58

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Primary skin irritation has been investigated according to FHSA test methods. The substance was slightly irritating to the skin of the albino rabbit.
Executive summary:

Primary skin irritation has been investigated according to FHSA test methods with 24 hours exposure to intact and abraded skin. The substance was slightly irritating to the skin of the albino rabbit.

Exposure was for a 24 hour period in contrast with 4 hours required by current OECD/EU test methods. However, the information obtained clearly demonstrate the substance to be only slightly irritating and classification as a skin irritant would not be required under the EU/GHS classification scheme.