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Toxicological information

Skin irritation / corrosion

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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