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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl cyanoacetate
EC Number:
236-425-5
EC Name:
2-ethylhexyl cyanoacetate
Cas Number:
13361-34-7
Molecular formula:
C11H19NO2
IUPAC Name:
2-ethylhexyl 2-cyanoacetate
Constituent 2
Reference substance name:
2-ethylhexyl-cyanoacetate
IUPAC Name:
2-ethylhexyl-cyanoacetate
Details on test material:
- Name of test substance: 2-ethylhexyl-cyanoacetate
- Chemical name: cyanoacetic acid 2-ethylhexyl ester
- Substance number: 96/219
- Batch number: ABL.NR . 13-9844
- CAS number: 13361-34-7
- Degree of purity/content: 98.5 g/100 g (GC)
- Date of manufacturing: 27-DEC-1995
- Physical state/appearance: liquid, yellowish, clear
- Stability under test conditions: The stability of the TS over the study period has been proven by reanalysis.
- Storage conditions: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH (Interfauna, UK)
- Age at study initiation: young adult animals
- Weight at study initiation: 3.19 - 3.98 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet: Kliba Labordiaet 341 (Klingenthalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: approx. 250 ml tap water per animal per day
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm, upper third of the back or flanks
- Type of wrap if used: The TS has been covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG


REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/Water (1:1)
- Time after start of exposure: 4 hours


SCORING SYSTEM: According to OECD guideline 404 (adopted July 17, 1992) and EEC L 383A, B.4 (December 29, 1992).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema. The skin findings were reversible in all animals within 48 hours after removal of the patches. Thus the study was terminated after 72 hours.

Any other information on results incl. tables

Irritant/corrosive response data for each individual animal at each time asa well as calculation of the means:

 

Animal

Erythema

Edema

1 hour

1

1

0

 

2

1

0

 

3

1

0

24 hours

1

1

0

 

2

0

0

 

3

0

0

48 hours

1

0

0

 

2

0

0

 

3

0

0

72 hours

1

0

0

 

2

0

0

 

3

0

0

Mean

1

0.3

0.0

 

2

0.0

0.0

 

3

0.0

0.0

Total mean

 

0.1

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the test conditions chosen and considering the described findings the TS does not give indication of an irritant property to the skin.