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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study Ethyl cyanoacetic acid and 2-ethylhexyl cyanoacetic acid are both esters of cyanoacetic acid, both hydrolyze rapidly under neutral and alkaline conditions to cyanoacetic acid and ethanol or 2-ethylhexanol, respectively. It ca be assumed that for most endpoints cyanoacetic acid will be the common metabolite that determines the toxicity of both substances.

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 (incl. QA statement)

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 cyanoacetate
Details on test material:
- Name of test material (as cited in study report): 2-ethylhexyl cyanoacetate / cyanoacetic acid 2-ethylhexylester
- Physical state: liquid
- Analytical purity: 98.5 %
- Lot/batch No.: Abl. Nr. 13-9844
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
other: HSDIF:NZW (SPF)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Barlan-Winkelmann GmbH
- Age at study initiation: young adult animals
- Weight at study initiation: 263-298 g
- Housing: single housing in stainless steel wire mesh cages
- Diet (e.g. ad libitum): Kliba Labordiät 341 (Klingentalmuehle AG)
- Water (e.g. ad libitum): ca. 250 ml tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact untreated skin
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (1 male/2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Application site: upper third of the back or flanks

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (R) and Lutrol (R)/water (1/1)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24 h; 48 h; 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal: #2 and #3
Time point:
other: mean 24 h; 48 h; 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1;#2 and #3
Time point:
other: mean 24 h; 48 h; 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU