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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Method: Fed. Register 38, No. 187, 27.09.1973 (Draize Test)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
p-[(2-chloroethyl)ethylamino]benzaldehyde
EC Number:
220-150-2
EC Name:
p-[(2-chloroethyl)ethylamino]benzaldehyde
Cas Number:
2643-07-4
Molecular formula:
C11H14ClNO
IUPAC Name:
4-[(2-chloroethyl)(ethyl)amino]benzaldehyde
Details on test material:
N-Ethyl-N-(2-chlorethyl)-p-amino-benzaldehyd (purity > 90 %)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 2.56 kg ; females: 2.91 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: intact skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml



Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: back skin, 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

SCORING SYSTEM:
according to Draize scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
Individual mean scores (24, 48, 72 h) for erythema/edema were 2.0/2.0 for all animals. After 8 days, surface necroses were observed in 2 animals, parchmentlike necroses in 1 animal. Strong skaling was observed after 8 days. Only cutaneous effects observed after treatment of intact skin are considered relevant for hazard assessment and are described in detail.

Any other information on results incl. tables

Skin readings on intact skin:

Animal

Erythema

Edema

24 hours

1

2

2

2

2

2

3

2

2

48 hours

1

2

2

2

2

2

3

2

2

72 hours

1

2

2

2

2

2

3

2

2

8 days

1

1

(sN)

1

2

1

(sN)

1

3

4

(pN)

1

 sN: surface necrosis; pN: parchment-like necrosis

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Classification: irritating