Bis(2-hydroxyethyl)ammonium acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1999-07-10 to 2000-04-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

The room temperature should be 20°C±3°C and not 22 ±3°C. This deviation is not thought to have affected the results of this study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

The room temperature should be 20°C±3°C and not 22 ±3°C. This deviation is not thought to have affected the results of this study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

RA1

IUPAC Name:

RA1

Test material form:

other: liquid

Details on test material:

- Physical state: Liquid
- Stability under test conditions: Maximum 365 days
- Storage condition of test material: At room temperature at about 20 ºC, away from direct sunlight

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes,
F-01400 Chatillon sur Charlaronne.
- Age at study initiation: Male: 15 weeks
Female: 15 weeks
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls with autoclaved wood and haysticks for chewing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 40 -70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light.


IN-LIFE DATES: From: 16-08-1999 To: 19-08-1999

Test system

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/animal

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 animals: 1 male, 2 female

Details on study design:

TEST SITE
- Area of exposure: Dorsal area
- Type of wrap if used: Semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The area was washed with lukewarm tap water
- Time after start of exposure: 4 hours following application

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours after removal of application

Score:

0

Max. score:

4

Remarks on result:

other: Reversibility not applicable as no irritation seen

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours after removal of application

Score:

0

Max. score:

4

Remarks on result:

other: Reversibility not applicable as no irritation seen

Irritant / corrosive response data:

The test article did not elicit any skin reactions at the appplication site at any of the observation times. The mean values from 24 to 72 hours were therefore 0/4 for erythema and 0/4 for oedema.

No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
No staining by the test article of the treated skin was observed.
The body weights of all rabbits were considered to be with in the normal range of variability.

Any other information on results incl. tables

Table 1: Body Weights

Body Weights in grams
Animal No.	Sex	First Day of Acclimatization	Day of Treatment	Last Day of Observation
10	Male	2585	2752	2782
11	Female	2503	2681	2679
12	Female	2579	2612	2668

Table 2: Skin Irritation Scores - Individual Values

Animal Number	Sex	Evaluation Interval	Erythema	Oedema
10 11 12	Male Female Female	1 hour	0 0 0	0 0 0
10 11 12	Male Female Female	24 hours	0 0 0	0 0 0
10 11 12	Male Female Female	48 hours	0 0 0	0 0 0
10 11 12	Male Female Female	72 hours	0 0 0	0 0 0

Table 3: Skin Irritation Scores - Mean values of 24, 48 and 72 hours

Animal Number	Sex	Erythema          N	Oedema             N
10 11 12	Male Female Female	0.00                   3 0.00                   3 0.00                   3	0.00                   3 0.00                   3 0.00                   3

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the classification criteria, RA1 is considered to be "not irritating" to rabbit skin following a 4-hr application.

Executive summary:

RA1 was tested for its dermal irritancy potential. 0.5 ml of test substance was applied to the skin of 3 White New Zealand rabbits for 4 hours using a semi-occlusive dressing. Following removal of the dressing and washing off the test substance, the animals were observed for 72 hours for signs of skin irritation, clinical signs, and changes in body weight.

The test article did not elicit any skin reactions at the appplication site at any of the observation times. The mean values at 24, 28 and 72 hours were 0/4 for erythema and 0/4 for oedema. The test substance did not induce any clinical signs in the treatment animals and all animals gained body weight during the course of the study.

Based on these results, RA1 is not considered to be a skin irritant.