2-Propenamide, N-(2-hydroxyethyl)-

Endpoint summary

Description of key information

Skin Irritation:

No dermal irritation was observed following a single semi-occlusive application of HEAA to intact rabbit skin for four hours.

Eye irritation:

The substance cause irreversible reactions in conjunctiva of two animals.

 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 September 1999 to 22 October 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch number: not advised
Purity: >99%

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Margate, Kent, England
- Age at study initiation: At least 12 weeks
- Weight at study initiation: 2.4 to 2.8 kg
- Housing: Individual stainlees steel cages with perforated floors.
- Diet (e.g. ad libitum): Special diet services, STANRAB (P) SQC pellet
- Water : ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 19°C
- Humidity (%): 31 to 58%
- Air changes (per hr): unknown
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml on 25 mm x 25 mm area

VEHICLE
- Amount(s) applied (volume or weight with unit): none

Duration of treatment / exposure:

4 hours

Observation period:

Day 1 approximately 60 minutes after removal of the dressings, days 2, 3 and 4.

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 25 mm x 25 mm
- % coverage: 100%
- Type of wrap if used: Semi-occlusive pad and gauze dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment site washed with warm water, at 38°C, to remove any residual test substance.
- Time after start of exposure: 4 hours.

SCORING SYSTEM: A primary Irritation index (PII) was calculated from the erythema and oedema scores according to the formula sa described in Technical Report No. 66"Skin irritation and corrosion: Reference chemicals data bank" (March 1995) ECTETOC, Brussels.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No dermal irritation was observed following a single semi-occlusive application of HEAA to intact rabbit skin for four hours.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

A single semi-occlusive application of HEAA to intact rabbit skin for four hours elicited no dermal irritation and HEAA is classified as a non-irritant.

Executive summary:

The study was performed to assess the skin irritation potential of HEAA to the rabbit, according to OECD Guideline 404, under GLP.

A single semi-occlusive application of HEAA to intact rabbit skin for four hours elicited no dermal irritation and HEAA is classified as a non-irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 June 2006 to 28 July 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Productions Bureau, 24 November 2000.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Lot number: 050804
Purity: >99%

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 21 weeks
- Weight at study initiation: 3.38 to 3.55 kg
- Housing: The rabbits were housed individually in plastic cages with perforated floors
- Diet : Each rabbit was offered 125 g of a standard laboratory rabbit diet (Rabbit GD Diet Pellets supplied by Highgate Farm) per day
- Water: ad libitum
- Acclimation period: All rabbits were acclimatised to the experimental environment for a period of approximately nine weeks prior to the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20°C
- Humidity (%): 40 to 70%
- Air changes (per hr): Unknown
- Photoperiod: 12 hrs dark / 12 hrs light

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Each rabbit was administered with a single ocular dose of 0.1 ml of the test substance.

VEHICLE
- Amount(s) applied (volume or weight with unit): None

Duration of treatment / exposure:

The dose was instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test substance was dropped. The eyelids were then gently held together for one second before releasing; the left eye remained untreated.

Observation period (in vivo):

Observations were taken at 1 hour and 24, 48 and 72 hours and at 8, 15 and 22 days.

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure:

SCORING SYSTEM: Kay and Calandra

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

not reversible

Remarks:

one animal reversed at day 8, two animals not reversed till day 22

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

Injection of the conjunctival blood vessels, a crimson-red or a beefy-red appearance was apparent in all cases throught the first week of observations; injection of the conjunctival blood vessels was stilll apparent at the end of the observation period in two animals. Moderate discharge was present in all animals with slight chemosis one hour after instillation.
Instillation of the test material gave rise to a moderate initial pain response in the sentinel animal, local ocular anaesthesia was employed for the subsequent animals. An apparent moderate initial pain response was also noted for these animals, however, since anaesthesia had been administered prior to test substance instillation, it is considered that these reactions were responses toward the physical instillation of dose rather than to a pain stimuli.

Other effects:

There was no sign of toxicity or ill health in any rabbit during the observation period.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The substance cause irreversible reactions in conjunctiva of two animals.

Executive summary:

The study was performed to assess the eye irritation potential of HEAA to the rabbit, according to OECD Guideline 405, under GLP.

The substance cause irreversible reactions in conjunctiva of two animals.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

The study was performed to assess the skin irritation potential of HEAA to the rabbit, according to OECD Guideline 404, under GLP. No dermal irritation was observed following a single semi-occlusive application of HEAA to intact rabbit skin for four hours.

Eye irritation:

The study was performed to assess the eye irritation potential of HEAA to the rabbit, according to OECD Guideline 405, under GLP. The substance cause irreversible reactions in conjunctiva of two animals.

 

Justification for classification or non-classification

Skin irritation / corrosion:

In vivo skin irritation, key study, OECD 404:

Mean score for erythema at 24, 48, 72 h for 3 tested animals: 0, 0, 0

Mean score for edema at 24, 48, 72 h for 3 tested animals: 0, 0, 0

According to Regulation (EC) No 1272/2008, table 3.2.2, this substance should not be classified for this endpoint.

 

Eye irritation:

In vivo eye irritation, key study, OECD 405:

Mean scores for cornea opacity, iris, conjunctivae and chemosis at 24, 48, and 72h:

cornea opacity: 0, 0, 0;

iris: 0, 0, 0;

conjunctivae: 2, 2, 1.3;

chemosis: 0, 0, 0.

The reactions on conjunctiva were irreversible in two animals till dady 22.

According to Regulation (EC) No 1272/2008, table 3.3.1, considering in two animals effects on conjunctiva not fully reversed within 21 days, this substance should be classified as Category 1 Irreversible effects on eyes.