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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Ethoxyamidin is not irritating to skin and slightly irritating to eyes.

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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 6 months
- Weight at study initiation: 2.1 - 2.5 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: pulverized solids were moistened with water
Controls:
other: the surrounding untreated skin served as control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch, non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: no residual test item had to be removed
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to DRAIZE
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
No systemic intolerance reactions were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In a dermal irritation study according to OECD TG 404 Ethoxyamidin Hydrochloride was applied under semiocclusive conditions for 4 hours to the shaved skin of 3 rabbits. Skin irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. The mean irritation index for erythema and edema was determined with 0.0, thus, the test material was not irritating to the skin of rabbits. No systemic intolerance reactions were observed.

According to classification criteria Ethoxyamidin HCl is not an irritant to the skin.

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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 4.5 months
- Weight at study initiation: 1.9 - 2.2 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
eye was not rinsed after administration of the test item
Observation period (in vivo):
1, 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1 and #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks:
on day 4 after instillation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #3
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks:
on day 2 after instillation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
on day 2 after instillation
Other effects:
No systemic intolerance reactions were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In an eye irritation study according to OECD TG 405 the test substance was instilled into the conjunctival sac of one eye of 3 male rabbits each. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. In this study slight irritation was seen as conjunctional redness (grade 1) up to 72 hours after instillation and conjunctival chemosis (grade 1) up to 24 hours after instillation. No systemic intolerance reactions were observed.

According to classification criteria Ethoxyamidin HCl is not an irritant to the eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

In a dermal irritation study according to OECD TG 404 Ethoxyamidin Hydrochloride was applied under semiocclusive conditions for 4 hours to the shaved skin of 3 rabbits. Skin irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. The mean irritation index for erythema and edema was determined with 0.0, thus, the test material was not irritating to the skin of rabbits. No systemic intolerance reactions were observed.

Eye irritation:

In an eye irritation study according to OECD TG 405 the test substance was instilled into the conjunctival sac of one eye of 3 male rabbits each. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. In this study slight irritation was seen as conjunctional redness (grade 1) up to 72 hours after instillation and conjunctival chemosis (grade 1) up to 24 hours after instillation. No systemic intolerance reactions were observed. Thus, the test material shows slight irritating effects to rabbit's eyes.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.