Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Feb.15, 1988 to June 13, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Three rabbits received the substance on an eye and skin. In the skin irritation test, 0.5 g of 1,3 -diphenylguanidine (Soxinol-D) was administered for 4 hours on 2 areas (scratched and intact areas) of the closed skin on the back of rabbits.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan Lab Animals Co., Ltd (Osaka, Japan)
- Age at study initiation: no data
- Weight at study initiation: 2.12 to 2.67 kg
- Housing: individually in an aluminium net cage with a suspension system
- Diet (e.g. ad libitum): ca. 100g/day solid rabbit food (CR-1, CLEA Japan, Inc, Osaka, Japan)
- Water (e.g. ad libitum): freely access to purified well water filtered
- Acclimation period: 21 to 35 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24+/-3°C
- Humidity (%): 60+/-15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: corn oil
Controls:
not required
Amount / concentration applied:
Patch was cut into 2,5 x 2,5 cm squares and damped with a small acount of corn oil, and then 0.5 g each of the test substance was evently dropped on the patches. The treated patches were administered to both of the scratched and intact areas and closed with a surgical tape for 4 hours.
Duration of treatment / exposure:
4 hours
Observation period:
4.5, 24, 48, 72 hours after administration
Number of animals:
3 rabbits (2 males, 1 female)
Details on study design:
TEST SITE
The furs on the back of 3 rabbits were shaved with an electric shaver at the size of 15 x 15 cm.
Two areas (one each on the both sides of the median plane) were designated for administration. One of the two areas for each animal was scratched , while the other area remained intact.
The scratches were made in a way so that only the stratum corneum was damaged and no bleeding or damage to corium was caused.

REMOVAL
After the 4 hours of administration, the patches were removed and the test substances left in the skin was wiped off with cotton containing acetone.

SCORING SYSTEM:
Skin reactions were numerically recorded followed the evaluation standards by Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin reaction, including erythema and edema, to the test substance was observed on either of the scratched or intact areas at 4.5, 24, 48 and 72 hours after the administration.
The primary irritation index is 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results, 1,3 -diphenylguanidine was considered to be non-irritating to rabbit skin.
Executive summary:

Three rabbits received the substance on an eye and skin. In the skin irritation test, 0.5 g of 1,3 -diphenylguanidine (Soxinol-D) was administered for 4 hours on 2 areas (scratched and intact areas) of the closed skin on the back of rabbits. No skin reaction, including erythema or edema, was observed on either of the scratched or intact during the observation period (72h).

Based on these results, 1,3 -diphenylguanidine was considered to be non-irritating to rabbit skin.