Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
November, 22nd - December 27th, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP guideline study

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
4-isopropylaniline
EC Number:
202-797-2
EC Name:
4-isopropylaniline
Cas Number:
99-88-7
Molecular formula:
C9H13N
IUPAC Name:
4-(propan-2-yl)aniline
Details on test material:
- Name of test material (as cited in study report): Cumidin
- Chemical name: 1-Amino-4-isopropylbenzol
- Physical state: brown viscous liquid
- Analytical purity: > 98 %
- Lot/batch No.: GKGB 155
- Expiration date of the lot/batch: not specified by the sponsor
- Storage condition of test material: darkness at room temperatrue in a fume cupboard

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 month
- Weight at study initiation: 2.3 - 3.5 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet, Altromin GmbH, Lage/Lippe
- Water (e.g. ad libitum): deionised, chlorinated water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/-3
- Humidity (%): 55 +/-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: November, 22nd - December 27th, 1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: hair was removed with an electric clipper
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours or 3 minutes
Observation period:
Examinations after 30 - 60 minutes, 24, 48 and 72 hours after removal of the patches. Additional readings 7 and 14 days after patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal region of the body
- Type of wrap if used: The substance was applied over the whole surface of a 2.5 cm x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): remnants of the test substance were removed with warm tap water.

SCORING SYSTEM: Draize scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean of
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Remarks:
after 14 d of observation
Remarks on result:
other: scar formation was visible at 14 d of observation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean of
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Remarks:
after 14 d of observation
Remarks on result:
other: scar formation was visible at 14 d of observation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean of
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
after 14 d of observation
Remarks on result:
other: scar formation was visible at 14 d of observation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean of
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
after 14 d of observation
Remarks on result:
other: scar formation was visible at 14 d of observation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean of
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
after 14 d of observation
Remarks on result:
other: scar formation was visible at 14 d of observation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean of
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
after 14 d of observation
Remarks on result:
other: scar formation was visible at 14 d of observation
Irritant / corrosive response data:
Treatment 4 hours: 1 h up to 14 d after removal of the test substance the animals exhibited well-defined up to moderate erythema as well as slight up to moderate oedema. The skin surface was discoloured brown, dry, rough, chapped, indurated and desquamation of coarse scales was noted. 14 d after application scar formation occured in all animals.
Treatment 3 minutes: 1 h up to 7 d after removal of the test substance the animals showed very slight up to moderate erythema. 2 and 3 days after removal a very slight oedema occured in one animal. The skin surface was dry and rough and desquamation of coarse scales was noted. After 14 d all irritations were reversible.

Any other information on results incl. tables

Table 1: Individual skin examination scores after 4h-exposure to Cumidin

(Scoring according to Draize scheme)a

 

Skineffect

Erythema

Edema

Scoringa

 

AnimalNo. /sex

0.5- 1 h

24h

48h

72h

7d

14d

Meanb

0.5- 1 h

24h

48h

72h

7d

14d

Meanb

#1 / f

2

2

3

3

2

2c

2.7

3

2

2

2

2

1c

2.0

#2 / f

2

2

3

3

2

2c

2.7

3

2

2

2

2

1c

2.0

#3 / f

3

3

3

3

2

2c

3.0

3

2

2

2

2

1c

2.0

a Timepoint of reading after substance removal subsequent to 4h-dermal exposure

b Mean of 24, 48 and 72 h scores

c Scar formation was visible in all three animals at 14 days after test substance removal

 

Table 2: Individual skin examination scores after 3 minutes-exposure to Cumidin

(Scoring according to Draize scheme)a

 

Skineffect

Erythema

Edema

Scoringa

 

AnimalNo. /sex

0.5- 1 h

24h

48h

72h

7d

14d

Meanb

0.5- 1 h

24h

48h

72h

7d

14d

Meanb

#1 / f

2

3

3

3

2

0

3.0

0

0

1

1

0

0

0.7

#2 / f

2

2

2

3

1

0

2.3

0

0

0

0

0

0

0.0

#3 / f

2

2

2

2

1

0

2.0

0

0

0

0

0

0

0.0

a Timepoint of reading after substance removal subsequent to 4h-dermal exposure

b Mean of 24, 48 and 72 h scores

 

Conclusion: According to EU: corrosive to skin, C R34

According to GHS: corrosive to skin, Category 1B

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
C R34; Skin corrosion Category 1B (according to GHS) Criteria used for interpretation of results: EU
Executive summary:

In a primary dermal irritation study, the skin corrosion potential of Cumidin was tested. The clipped dorso-lateral skin of the trunk of three female New Zealand White rabbits was exposed to 0.5 mL test material for 4 hours or 3 minutes under semi-occlusive conditions. The rabbits were observed for 14 days. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48 and 72 hours as well as 7 and 14 days after removal of the test substance.

The exposure period of 4 hours caused non reversible skin damages resulting in scar formation which was seen during the whole observation period of 14 days after removal of the test substance.

The exposure period of 3 minutes resulted in slight to moderate erythema and very slight oedema, which was fully reversible within 14 days.