Registration Dossier

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:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSA - 16CFR1500.41
Deviations:
no
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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Lot/batch No.: 013

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
24 hours
Observation period:
72 hours
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: Test substance placed onto surgical gauze patches held in contact with the skin by adhesive tape. Trunk of the animal then wrapped with impervious tape for duration of exposure period

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- 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:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
4.4
Max. score:
8
Reversibility:
not specified
Remarks on result:
other: FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Intact skin FHSA test - Observation at 24 & 72 hours only
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.25
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Intact skin FHSA test - Observation at 24 & 72 hours only

Any other information on results incl. tables

Intact skin

Animal No.

Erythema

Oedema

24 hours

72 hours

24 hours

72 hours

1

2

2

2

2

2

2

2

2

3

3

2

2

2

2

4

1

3

1

3

5

2

2

2

3

6

2

2

2

3

Mean

2.0

2.3

 

Abraded skin

Animal No.

Erythema

Oedema

24 hours

72 hours

24 hours

72 hours

1

2

2

3

2

2

2

2

2

3

3

2

2

2

2

4

1

3

1

3

5

2

4

2

3

6

2

2

2

3

Mean

2.2

2.3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Primary skin irritation has been investigated according to FHSA test methods. Based on the available information, (erythema score 2.00, oedema score 2.25), the substance is not a dermal irritant according to CLP (1272/2008/EEC).
The conditions of the available study are more stringent, in particular the 24 hour exposure period compared with 4 hours of current test methods (described in OECD TG 404), and are thus regarded as worst case scenario. In conclusion the substance is not classified skin irritating based on CLP.
Executive summary:

In a primary dermal irritation study, rabbits were dermally exposed to 0.5 mL of 4 -MHHPA for 24 hours. Reaction was assessed after 24 and 72 hours and assigned a numerical score according to the Draize scale. .

A mean erythema score (24 - 72 hours),calculated over all 6 animals, for intact skin of 2.00 and for abraded skin of 2.33 was observed. The oedema score was determined to be 2.25 for intact skin and 2.67 for abraded skin.

Taking the test conditions into account, in particular the 24 hour exposure period compared with 4 hours of current test methods described in OECD TG 404, 4 -MHHPA has not to be classified and labelled as dermal irritant according to CLP (1272/2008/EEC).