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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:
1973
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Identity FAT 65004/F TE
Batch 15060201 (China)
Purity determined in this study
Appearance
Smell
yellowish powder, solid at 20°C
neutral
pH-Value pH-value of a soln. of 2% (w/w) = 6.90
Expiration date August 25th, 2020
Storage to be stored at room-temperature
Specific details on test material used for the study:
None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animals:
Healthy New Zealand White rabbits (Porton strain) aged 3 -• 4 months with average body weights of 3.73 Kgs. (male) and 3.30 Kgs. (female), bred on. the premises and maintained under a semi-barrier system. Six rabbits (3 male and 3 female) were acclimatized in the test area for one week prior to the start of the trial.
Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (±1°) and a relative humidity of 50-70 %. Animals were exposed to artificial light for 15 hours daily from 08.00 - 23.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml. of the compound was applied on a 2.5 cm. square sterile gauze pad to each test site
Duration of treatment / exposure:
24 hrs
Observation period:
72 hrs
Number of animals:
6 aminals (3 male and 3 female)
Details on study design:
The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.

0.5 ml. of the compound was applied on a 2.5 cm. square sterile gauze pad to each test site. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours.
The assessment of the macroscopic skin reaction was made according to Draie grading system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin reaction occurred
Other effects:
none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Compound FAT 65 004 is not a primary skin irritant in the albino rabbit.
Executive summary:

The test was carried out according to the method given in the"Hazardous Substances Regulations" under the U.S. Federal HazardousSubstances Labelling Act Sect. 191.11 (February 1965).

Healthy NewZealand White rabbits (Porton strain) aged 3 -4months with average body weights of 3.73 Kgs. (male) and 3.30 Kgs.(female),bred on. the premises and maintained under a semi-barriersystem. Six rabbits(3 maleand 3female) were acclimatized in the testarea for oneweek prior to the start of the trial.

 

Twenty-four hours prior to the dermal application, the backs ofthe rabbits were shaved over an area consisting of at least10%ofthe total body surface. Two test sites lateral to the mid line ofthe back were used on each rabbit. Immediately before theapplication of the test compound, the right hand site was abradedwiththe point of a sterile hypodermic needle. The abrasions weresufficiently deep to penetrate the stratum corneum but not to damagethe dermis. The left hand site remained intact.

 

0.5 ml. of the compound was applied on a 2.5 cm. squaresterile gauze pad to each test site.These were covered with aluminium foil secured with "Sleek" adhesivetape. The test sites were then enclosed by a 6" wide "Coban" selfadhesive bandage the edges of which were fixed to the skin by stripsof "Sleek" in order to retain the test substance in close contactwith the skin.

 

After 24 hours the dressing was removed and the intact andabraded application sites were assessed for oedema and erythema.A further assessment was made at 72 hours.

The assessment of the macroscopic skin reaction was madeaccording toDraiegrading system.

Compound FAT 65 004 is not a primary skin irritant in the albino rabbit.