Cyclopropanecarbonitrile, 1-amino-, hydrochloride (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Skin irritation was determined according to OECD Guideline 404 Acute Dermal Irritation / Corrosion.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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

Test material information

Constituent 1

Reference substance name:

1-Amino-1-cyclopropanecarbonitrile hydrochloride

EC Number:

629-718-8

Cas Number:

127946-77-4

Molecular formula:

C4H7N2Cl

IUPAC Name:

1-Amino-1-cyclopropanecarbonitrile hydrochloride

Constituent 2

Reference substance name:

1-aminocyclopropane-1-carbonitrile hydrochloride

IUPAC Name:

1-aminocyclopropane-1-carbonitrile hydrochloride

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Millbrook Breeding Labs, Amherst, MA
-Sex: 2 males and 1 female
-Age: at least to 10 weeks olds (adult)
-Weight: 2.07 - 2.15 kilograms
-Housing: individually housed, cages: suspended stainless steel, bedding: hardwood chips.
- Diet: TEK 8630 Rabbit diet, Harlan Teklad, Madison, WI, ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum of 5 days under the same conditions as for the test.

ENVIRONMENTAL CONDITIONS
-Temperature: 68°F
-Humidity: 30-70%
-Air changes: 10 to 15 per hr
-Photoperiod: 12 hrs dark/light cycle, full spectrum fluorescent lights.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

Sterile Water for Injection (WFI)

Controls:

other: The untreated areas of the skin of the animal as a control.

Amount / concentration applied:

The test substance (0.5g) was moistened with 0.1 mL of Sterile Water for Injection and applied directly to the skin of the rabbits (approximately on 6cm3). Each application area was covered with a gauze patch, which was held in place with non-irritant tape.

Duration of treatment / exposure:

Exposure period: 4 hours.

Observation period:

After the exposure period, animals were observed for signs of erythema and edema at 60 minutes, and then at 24, 48 and 72 hours after patch removal.

Number of animals:

3 animals (2 males and 1 female)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 60 minutes, 24, 48 and 72 hours

Score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 60 minutes, 24, 48 and 72 hours

Score:

0

Reversibility:

other: Not applicable

Irritant / corrosive response data:

The test substance was evaluated for its potential to produce primary dermal irritation or corrosion after a single topical 4 hour application to the skin of New Zealand White rabbits. No signs of erythema or edema wer noted at any observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test substance is considered a non-irritant.