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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:
September 9, 1987 to September 16, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
performed prior to the GLP guidance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
TEST MATERIAL
Sample label: 1177-87
On arrival at the testing facility the material was further coded with a reference number.
Tox ref No. A/S/2747


Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Health female New Zealand White rabbits were obtained from A. Smith Warlingham Surrey and were delivered by road tranposrt on 14th August 1987.On arrival animals were identified by tatoo in the ear with an individual number. Animals were allowed an acclimatization period of twenty six days.
The rabbits were individually housed in grid bottomed metal cages. A commercially available antibiotic free rabbit diet and mains drinking water via automatic nozzles in each cage were available ad libitium. The rabbit holding room was air conditioned with temperature in the range of 15 - 23 °C and relative humidity in the range of 46 - 91 % during the acclimatisation and study periods.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,5 ml undiluted
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
4 rabbits
Details on study design:
On the day of dosing selected animals were placed in restraining stocks. 0,5 ml of one test material was placed evenly over a 2,5 cm square of surgical lint. The lint square was then placed onto the animal's skin, on the left flank and immediately caudal to the last rib, with the test material in contact with skin.
A second material was applied in the same manner to the skin on the right flank, bilateral to the first material. Two other materials were applied caudal to the sites dosed with the first two mterials.
The lint patches were held in place encircling the trunk of the animal with a lenght of Elastoplast elastic adhesive bandage 10 cm wide. This also served as a semi occlisive barrier to the treat skin.
All rabbits were treated in the same manner, the four test materials being placed in different positions on the back of each animal of the group.
Animals remained in the restraining stocks during the dosing period. After a period of four hours the adhesive tapes were removed and the treated sites cleansed by gentle swabbing with cotton wool saoked in warm water. The animal were then returned to their cage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 91, 93 and 113
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 92
Time point:
24/48/72 h
Score:
1.5
Max. score:
1.5
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 91
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 92
Time point:
24/48/72 h
Score:
0.33
Max. score:
0.5
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 93
Time point:
24/48/72 h
Score:
1
Max. score:
1.5
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 113
Time point:
24/48/72 h
Score:
0.83
Max. score:
1
Reversibility:
not fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
Based on the results main score obtained for erythema and oedema, it can be concluded that TETRAHYDRO CITRAL does not meet the criteria for skin irritation classication according the CLP Regulation (EC) No. 1272/2008 but it can be considered as mild skin irritant Cat 3 based on GHS criteria.
Executive summary:

The skin irritation potential of TETRAHYDRO CITRAL was investigated by topical semi­ occlusive application test in four New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the four animals was 2 for three aniamals and 1,5 for an other, and the mean oedema score was 0.67, 0.33, 1, nd 0.83 for the four animals respectively.

Based on the results main score obtained for erythema and oedema, it can be concluded that TETRAHYDRO CITRAL does not meet the criteria for skin irritation classication according the CLP Regulation (EC) No. 1272/2008 but  it can be considered as mild skin irritant Cat 3 based on GHS criteria.