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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in-vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-02-04 - 1993-04-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EEC directive 84/449/EEC
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2,6-diisopropylphenyl)carbodiimide
EC Number:
218-487-5
EC Name:
Bis(2,6-diisopropylphenyl)carbodiimide
Cas Number:
2162-74-5
Molecular formula:
C25H34N2
IUPAC Name:
N,N'-bis[2,6-bis(propan-2-yl)phenyl]methanediimine
Details on test material:
- Name of test material: bis(2.6-diisopropylphenyl)carbodiimide
- Substance type: organic technical product
- Physical state: white powder
- Lot/batch no. MT92003
- Identification: labelled, where appropriate, with name of test article, batch no., name of sponsor, project no., date of receipt, storage conditions, handling precautions and expiration date
- Storage: ambient, protected from humidity
- Stability: 2 years
- Solvent/vehicle: none

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever; Kaninchenfarm, Bremervörde, Neuendamm
- Animal selection: random
- Animal identification: with individual ear tags; cage labelled with ear tag no., sex, date of study initiation, project no.
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): Ssniff K-Haltung (Ssniff Spezialdiäten GmbH, Soest/Westfalen, Germany)
- Water (e.g. ad libitum): ad libitum (half-yearly analyses and bacteriological tests)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 30 - 70 % (Measurement: with thermo hygrometer twice daily)
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: fur was removed with electric clippers
Vehicle:
water
Remarks:
moistened sufficiently with aqua ad injectabilia to ensure good contact with the skin
Controls:
other: an adjacent area of untreated skin served as control
Amount / concentration applied:
0.5 g on about 6 cm² in size
Duration of treatment / exposure:
4 h
Observation period:
30-60 min, 24, 48 and 72 h after patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: roughly 8 x 15 cm on the back of each animal
- % coverage:
- Type of wrap if used: each test area was covered with a semi-occlusive dressing consisting of Ypsiplast® (Holthaus Medical, Remscheid-Lüttringhausen), which was held in place by non-irritating tape Elastoplast® (Beiersdorf AG, Hamburg), and Stülpa® (P. Hartmann AG, Heidenheim-Brenz), which enveloped the whole of the animal's trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 4-h exposure period, the dressing was removed and any residual sample was carefully washed off with water or an appropriate solvent.
- Time after start of exposure: 4 hours

24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. The skin was examined for abrasions and only animals with healthy, intact skin were used in the test.
The solid test article was moistened sufficiently with Aqua ad injectabilia to ensure a good contact with the skin.
In each animal, 0.5 g of the test article were applied to the test site (ca. 6 cm² in size), an adjacent area of untreated skin serving as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60 minutes and 24; 48; 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60 min and 24; 48; 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
No test article-dependent findings were observed. No toxic effects were observed.
Other effects:
No other effects reported

Any other information on results incl. tables

Table 1: individual detailed data

 

Time after patch removal

Animal number

30-60 min

24 h

48 h

72 h

 

Ery

Oed

Ery

Oed

Ery

Oed

Ery

Oed

 

T

C

T

C

T

C

T

C

T

C

T

C

T

C

T

C

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

T= test site,

C= control site,

Ery = erythema,

Oed = oedema.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The study was performed according to the OECD Guideline 404 with no deviations and according to the good laboratory practice principles, it is considered to be of the highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. The mean grades of skin reactions at 24, 48 and 72 h after patch removal were lower than the value classified as irritant by the European regulation (EC) No. 1272/2008, amending regulation EC no. 1907/2006 (REACh). When applied to the skin, the test article may therefore be considered to be non-irritant. The test material did not induce irritation on the intact skin of rabbits. The product bis(2.6-diisopropylphenyl)carbodiimide is considered to be not irritating to the skin.
Executive summary:

The skin irritation potential of the test substance was investigated in rabbits (Kaufmann, 1993, according to TG OECD 404). Bis(2.6-diisopropylphenyl)carbodiimide was applied to the skin of rabbit (skin prepared with electric clippers, 0.5 mg pure substance moistened with water) for 4 hours under semiocclusive conditions. The study was performed according to the OECD Guideline 404 with no deviations and according to the good laboratory practice principles, it is considered to be of the highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. After this period the skin was evaluated 30- 60 min, 24, 48 and 72 h after patch removal. No test article- dependent findings were observed. The mean grades of skin reactions were lower than the value classified as irritant by the European regulation (EC) No. 1272/2008, amending regulation EC no. 1907/2006 (REACh). When applied to the skin, the test article may therefore be considered to be non- irritant.