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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1989-08-29 to 1989-09-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The reliability of the original study used in Read Across is 1. Justification for Read Across is given in Section 13 of IUCLID.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

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: Dr. K. Thomae GmbH Chemisch-pharmazeutscieh Fabrik D-7950 Biberach/Riss.
- Acclimatisation period: at least 5 days.
- Housing: one animal per cage at 20 ± 3 °C, 30-70 % relative humidity and 12 hours light cycle day.
- Diet: ad libitum Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland.
- Water: ad libitum.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g of test substance applied
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: 12-16 cm².
- % coverage: full.
- Type of wrap if used: covered with aluminum foil (approx. 36 cm2) and held in place with adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

REMOVAL OF TEST SUBSTANCE
- Washing: not specified.
- Time after start of exposure: 4 hours.

SCORING SYSTEM:
- Method of calculation: Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Max. score:
0
Remarks on result:
not determinable
Remarks:
due to colouration of the skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The indiviual scores are presented in Table 1 (see box "Any other information on results incl. tables"). No erythema scores according to Draize were awarded due to colouration of the skin by the test substance for the first 24 hours. From 48 hours to 72 hours no reactions were observed.

Any other information on results incl. tables

Table 1: Individual skin reaction score

 

Erythema

Edema

Animal number

660/F

CF/TF

954/F

CF/TF

976/F

CF/TF

660/F

CF/TF

954/F

CF/TF

976/F

CF/TF

After 1 h

0/*

0/*

0/*

0/0

0/0

0/0

After 24 h

0/*

0/*

0/*

0/0

0/0

0/0

After 48 h

0/0

0/0

0/0

0/0

0/0

0/0

After 72 h

0/0

0/0

0/0

0/0

0/0

0/0

Mean 24-72 h

0/0#

0/0#

0/0#

0/0

0/0

0/0

 

CF= control flank             TF = test flank

M = male                            F = female

* = dark blue staining   # = mean 48 - 72 hours 

Applicant's summary and conclusion

Interpretation of results:
other: not classified as skin irritant according to the CLP Regulation (EC) No.1272/2008
Conclusions:
In the acute dermal irritation/corrosion study according to OECD 404 the test item is considered to be non-irritating to the skin.
Executive summary:

In a primary dermal irritation study, three female New Zealand White rabbits (approx. 12 -14 weeks old, 2160 - 2990 g) were dermally exposed to 0.5 g of the test item on a moistened gauze patch to the shaved flank. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize.

In this study, the test item is not a dermal irritant.