2-(2-aminoethoxy)ethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-10-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to OECD 404 guideline and in compliance with the GLP Regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report Date:

1992

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. certificate)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): 6398-21-1
- Physical state: clear, colorless liquid
- Analytical purity: responsibility of the Sponsor
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Other: total amount submitted :1408.3g (materials and containers)/pH=10 (litmus paper)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Hare-Marland, Hewitt, NJ
- Age at study initiation: adult
- Weight at study initiation: 2.504-2.865 kg
- Housing:Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the
Institute of Laboratory Animal Resources, National Research Council.
- Diet (e.g. ad libitum): Purina Rabbit Ration HF, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum.
- Acclimation period: min.5d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C (63-73°F)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light):12h light, 12h dark


IN-LIFE DATES: From: To:

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: OECD 404: untreated area of the test animal serves as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL/site

Duration of treatment / exposure:

4h (upper: intact dorsal trunk)
24h (lower: intact and abraded dorsal trunk)

Observation period:

14d

Number of animals:

6 (3M and 3F)

Details on study design:

TEST SITE
- Area of exposure: dorsal trunk (clipped free of fur)
- Type of wrap if used: rubber dam and an elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 4 and 24h


SCORING SYSTEM: observation
Draize Evaluation of Dermal Irritation (Primary Irritation Index) and Modified Primary Irritation Index

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

8

Remarks on result:

other: 8=severe dermal irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal: 6/6

Time point:

other: 30min (4h exposure)

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

14d observation

Remarks on result:

other: severe erythema, sloughing, fissuring and necrosis

Results 3

Irritation parameter:

edema score

Basis:

animal: 6/6

Time point:

other: 30min (4h exposure)

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

14d observation

Remarks on result:

other: severe edema, sloughing, fissuring and necrosis

Results 4

Irritation parameter:

erythema score

Basis:

animal: 6/6

Time point:

other: 24h (24h exposure)

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

14d observation

Remarks on result:

other: severe erythema, necrosis, sloughing and fissuring

Results 5

Irritation parameter:

edema score

Basis:

animal: 6/6

Time point:

other: 24h (24h exposure)

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

14d observation

Remarks on result:

other: severe edema, sloughing and fissuring

Irritant / corrosive response data:

irreversible severe erythema (including necrosis, sloughing, fissuring) and severe edema is observed 30 min after 4h exposure. The skin damage remained throughout the study (14d)

Applicant's summary and conclusion

Conclusions:

The test article was considered to be a severe dermal irritant at both 4 and 24 hour exposures.