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Description of key information

The available data suggests that amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) irritating to skin and moderately 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:
From January 9, 1990 to February 14, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD 404 guideline study, but not in compliance with GLP.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: Single animals in steel cages
- Diet (e.g. ad libitum): K4 diet for rabbit, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): yes
- Acclimation period: 14 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11-01-1990 To: 05-02-1990
Type of coverage:
occlusive
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 cm3 of product on a 6 cm2 skin surface
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 h
Observation period:
25 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100%
- Type of wrap if used: application site covered with gauze. Additional wWrapping with an elastic band.


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


SCORING SYSTEM: OECD 404 method
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Not applicable
Score:
7
Max. score:
8
Remarks on result:
other: Highly irritating
Irritant / corrosive response data:
No details provided
Other effects:
None

Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 days, 2/3 animals had fully recovered. In the third animal, scabs were falling away.

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the undiluted test substance was considered to be highly irritating to rabbit skin. Further, according to CLP, the test substance may be considered to be Category 2 skin irritant.
Executive summary:

A study was conducted to assess the irritation potential of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) to rabbit skin according to OECD Guideline 404. The test substance was applied undiluted to rabbit skin under an occlusive bandage for 4 h, then washed away with warm water. Animals were observed for 25 d.

Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 d, 2/3 animals had fully recovered. In the third animal, scabs were falling away.

The overall irritation index was 7/8 so that the undiluted test substance can be considered highly irritating to rabbit skin under the conditions of the study. Further, according to CLP, the test substance may be considered to be Category 2 skin irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
From January 23, 1990 to February 14, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD 405 guideline study, but not in compliance with GLP.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: Single animals in steel cages
- Diet (e.g. ad libitum): K4 diet for rabbits, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): yes
- Acclimation period: 14 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 23-01-1990 To: 09-02-1990
Vehicle:
unchanged (no vehicle)
Controls:
other: Right eye of each animal was untreated and served as control
Duration of treatment / exposure:
72 h
Observation period (in vivo):
17 d
Number of animals or in vitro replicates:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Not applicable
Score:
34.9
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: Moderately irritating
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Not applicable
Score:
1.33
Reversibility:
fully reversible within: 10 d
Remarks on result:
other: 2/3 animals showed corneal opacity, reversible within 10 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Not applicable
Score:
0.56
Reversibility:
fully reversible within: 10 d
Remarks on result:
other: 2/3 animals showed redness and circumcorneal injection, reversible within 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Not applicable
Score:
1.11
Reversibility:
fully reversible within: 13d
Remarks on result:
other: 3/3 animals showed light swellingof the conjunctivae, reversible within 13 days
Irritation parameter:
other: Erythema score
Basis:
mean
Time point:
other: Not applicable
Score:
2.77
Reversibility:
fully reversible within: 13 d
Remarks on result:
other: 3/3 animals showed strong erythema, reversible within 13 days
Other effects:
No details provided
Interpretation of results:
Category II
Remarks:
Migrated information Irritating to eyes Criteria used for interpretation of results: EU
Conclusions:
Under the study conditions, the test substance was considered to be moderately irritating to the rabbit eye. Further, according to CLP, the test substance may be considered to be Category 2 eye irritant.
Executive summary:

A study was conducted to determine the irritation potential of the test substence to rabbit eye according to OECD Guideline 405.

The test substance was applied neat to the left eye of three rabbits. Animals were then observed for 17 days.

Two out of three animals showed opacity of the cornea as well as slight corneal reddening and circumcorneal injection. These effects were reversible within 10 days. In all animals, moderate to strong erythema and slight swelling of the conjunctivae were noted. This was reversible within 13 days. The overall irritation index was 34.9/110.

Under the conditions of this study, the test substance was considered moderately irritating to rabbit eye. Further, according to CLP, the test substance may be considered to be Category 2 eye irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A study was conducted to assess the irritation potential of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) to rabbit skin according to OECD guideline 404. The test substance was applied undiluted to rabbit skin under an occlusive bandage for 4 hours, then washed away with warm water. Animals were observed for 25 days. Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 days, two out of three animals had fully recovered. In the third animal, scabs were falling away. The overall irritation index was 7/8 which indicates that the substance is irritating to rabbit skin under the conditions of the study (Mürmann P, 1990).

According to CLP, the test substance may be considered to be category 2 skin irritant.

Eye irritation:

A study was conducted to determine the irritation potential of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) to rabbit eye according to OECD guideline 405. The test substance was applied neat to the left eye of three rabbits. Animals were then observed for 17 days. Two out of three animals showed opacity of the cornea as well as slight corneal reddening and circumcorneal injection. These effects were reversible within 10 days. In all animals, moderate to strong erythema and slight swelling of the conjunctivae were noted. This was reversible within 13 days. The overall irritation index was 34.9/110 which indicates the substance to be a moderate irritant to rabbit eye (Mürmann P, 1990).

According to CLP, the test substance may be considered to be category 2 eye irritant.

Justification for selection of skin irritation / corrosion endpoint:

Only one guideline compliant study was available.

Justification for selection of eye irritation endpoint:

Only one guideline compliant study was available.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin

Based on the available reliable in vivo skin irritation study conducted according to the OECD 404 guideline, a 4-h, occlusive exposure to undiluted amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) clearly indicates irritation response to skin. Hence, the data justifies R38 classification according to EC criteria (67/548/EEC) and skin irritation category 2; H315-causes skin irritation (hazard statement) according to CLP criteria (EC 1272/2008).

Eye

Based on the available reliablein vivoeye irritation study conducted according to the OECD 405 guideline, an instillation of undiluted test substance,amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl)into rabbit eyes clearly indicates irritation response. Hence, the data justifies

R36 classification according to EC criteria (67/548/EEC) and eye irritation category 2; H319 -causes serious eye irritation (hazard statement) according to CLP criteria (EC 1272/2008).

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