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Description of key information

Skin: in vivo, rabbit, semiocclusive, 4h, OECD 404: Moderate to severe skin reactions, erythema 2.7 and oedema 2.8, full reversible within 21 days (Cognis 1997).

Eye: in vivo, rabbit, OECD 405: Moderate to severe eye reactions, cornea opacity 1.0; iris lesion 0.0; redness of conjunctiva 2.6; oedema of conjunctiva 2.8, full reversible within 21 days (Cognis 1997).
Respiratory system: in vivo, rat, OECD 403, LC50 mixture of dimethylamides (mainly C8/C10): >3551 mg/m3, but irritation of the respiratory tract (e.g. slower breathing, serous nasal discharge, dyspnea, stridor, hypothermia) (Bayer 1991)

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623
- Weight: 2.3-2.5 kg
- Housing: animal room 2, filtered Air, ppo cages
- Diet (e.g. ad libitum): ad libitum / Altromin 2123 , Altromin , Lage , Germany
- Water (e.g. ad libitum): ad libitum (acified, HCl)
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 55±15%
- Air changes (per hr): 10times/h
- Photoperiod (hrs dark / hrs light):12h each
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4h
Observation period:
1h, 24h, 48h, 72h, 7d, 14d, 21d
Number of animals:
3
Details on study design:
TEST SITE
- Clipped area: 10*10cm
- Area of exposure: 2.5cm*2.5cm
- % coverage: 100
- Type of wrap if used: 16-layer gaze fixed with 2.5cm adhesive Gothaplast tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin was cleaned with mild soap and lukewarm water
- Time after start of exposure: 4h
Irritation parameter:
erythema score
Remarks:
Erythema and Eschar Formation
Basis:
mean
Remarks:
three animals
Time point:
other: mean of 24h, 48h and 72h reading
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: after 21 days rests of scales were observed in all animals
Irritation parameter:
edema score
Remarks:
Oedema Foramtion
Basis:
mean
Remarks:
three animals
Time point:
other: mean of 24h, 48h and 72h reading
Score:
2.8
Max. score:
4
Reversibility:
fully reversible within: after 21 days rests of scales were observed in all animals
Irritant / corrosive response data:
no evidence for corrosion reported
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
irritating to skin
Executive summary:

The acute skin irritant effect of the test substance was investigated according to the method recommended in the OECD Guideline No. 404, "Acute Dermal Irritation/Corrosion", 1992, and EEC Guideline B.4 "Acute Toxicity (Skin Irritation)", 29.12.1992.

Three female albino rabbits were exposed to the test article at two skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after termination of exposure.

Moderate to severe skin reactions were observed.

Under the experimental conditions described in this report, the mean score for erythema was 2.7 (2.00, 3.00, 3.00) and for oedema 2.8 (2.00, 3.33, 3,00). After 21 days rests of scales on both sides were observed in all animals.

Based on this result the substance has to be labeled as irritating to skin according to EU GHS EC 1272/2008.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S
- Weight: 2.4-2.6kg
- Housing: animal room 2, filtered Air, ppo cages
- Diet (e.g. ad libitum): ad libitum / Altromin 2123 , Altromin , Lage , Germany
- Water (e.g. ad libitum): ad libitum (acified, HCl)
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 55±15%
- Air changes (per hr): 10times/h
- Photoperiod (hrs dark / hrs light):12h each

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
Observation period (in vivo):
1h, 24h, 48h, 72h, 7d, 14d, 21d
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Remarks:
corne opacity
Basis:
mean
Remarks:
three animals
Time point:
other: mean from 24h, 48h and 72h reading
Score:
<= 1
Max. score:
4
Reversibility:
fully reversible within: 21 days in 2 of 3 animals
Remarks on result:
other: When Fluorescein has been applied only the highest score for degree of corneal opacity from three readings are included
Irritation parameter:
iris score
Remarks:
iris lesion
Basis:
mean
Remarks:
three animals
Time point:
other: mean from 24h, 48h and 72h reading
Score:
<= 0
Max. score:
2
Remarks on result:
other: normal reaction observed
Irritation parameter:
conjunctivae score
Remarks:
redness of conjunctiva
Basis:
mean
Remarks:
three animals
Time point:
other: mean from 24h, 48h and 72h reading
Score:
<= 2.6
Max. score:
3
Reversibility:
fully reversible within: 21 days in 2 of 3 animals
Irritation parameter:
chemosis score
Remarks:
oedema of conjunctiva (chemosis)
Basis:
mean
Remarks:
three animals
Time point:
other: mean from 24h, 48h and 72h reading
Score:
<= 2.8
Max. score:
4
Reversibility:
fully reversible within: 21 days in 2 of 3 animals
Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Eye irritant potential
Executive summary:

The eye irritant effect of of the test substance (N,N-Dimethyldecan-1-amide) was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", 29.12.1992.

Three female albino rabbits were exposed to 0.1 ml of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7, 14 and in two animals 21 days after dosing.

Moderate to severe signs of eye irritation were observed among the rabbits.

The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

Cornea opacity 1.0

Iris lesion 0.0

Redness of conjunctiva 2.6

Oedema of conjunctiva 2.8

After 14 days all animals showed hairless areas around the eye. Treatment related adverse eye reactions were fully reverse within 14 (1 animal) and 21 days.

Based on the result of this study the test substance is classified as eye irritant

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Valid experimental data is available for the assessment of skin and eye irritation.

Skin:

The acute skin irritant effect of N,N-Dimethyldecan-1-amide was investigated according to OECD Guideline No. 404 and EEC Guideline B.4 (Cognis 1997). Three female albino rabbits were exposed to the test article at two skin sites on the back. After 4hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after termination of exposure. Moderate to severe skin reactions were observed. Under the experimental conditions described in this report, the mean score for erythema was 2.7 (2.00, 3.00, 3.00) and for oedema 2.8 (2.00, 3.33, 3,00). After 21 days rests of scales on both sides were observed in all animals.

Eye:

The acute eye irritant effect of N,N-Dimethyldecan-1-amide was investigated according to the method recommended in the OECD Guideline No. 405 and EEC Guideline B.5 (Cognis 1997).Three female albino rabbits were exposed to 0.1 ml of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7, 14 and in two animals 21 days after dosing. Moderate to severe signs of eye irritation were observed among the rabbits. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated: Cornea opacity 1.0; Iris lesion 0.0; Redness of conjunctiva 2.6; Oedema of conjunctiva 2.8. After 14 days all animals showed hairless areas around the eye. Treatment related adverse eye reactions were fully reversible within 14 (1 animal) and 21 days.

Key study assignment:

As there is only one reliable and relevant study available for each endpoint, this study has been used as key study.

Additional information for respiratory irritation:

Acute inhalation toxicity (mixture of dimethylamides):

A study for acute inhalation toxicity was conducted with a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyl-dodecanamide and N,N-dimethyl-hexanamide) in accordance with OECD Guideline No. 403 (Bayer 1991). Therefore 5 SPF-bred Wistar rats were exposed (head/nose only) to 118.5; 586.4; 2007.6 and 3550.7 mg/m3 (analytical determined).Rats subjected to a concentration of 119 mg/m3 air tolerated the exposure without signs occurring. Rats exposed to 586 mg/m3 air exhibited a transient reddening of the nose on the day of exposure and reduced motility. Rats subjected to the max. tested concentration (3551 mg/m3 air; nebulisation of the undiluted test article) exhibited persistent signs causally linked to an irritation of the respiratory tract (slower breathing, serous nasal discharge, dyspnea, stridor, hypothermia). 3551 mg/m3 air was the range at which mortality started for male rats (1 of 5 died). The results of this study show that the respirable test article aerosol had a relatively low acute inhalation toxicity in the rat. The acute potential hazard of the respiratory tract is attributed to the potency of the test substance aerosol to act as a mucosa irritant. LC50 inhalation (aerosol) Rat (exposure: 4 h) > 3551 mg/m3 air.

It must also be noted that such a high concentration of 3551 mg/m3 (analytically determined) is created by a nominal concentration of 50000 mg/m3


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Skin:

Clear skin irritating effects were observed in a skin irritation study: The scores obtained from the study led to a classification as an irritant to skin (cat. 2) due to criteria of GHS (Regulation (EU) 1272/2008).

Eye:

Clear eye irritating effects were observed in an eye irritation study: The scores obtained in this study led to a classification as an irritating to eye (cat. 2) due to criteria of GHS (Regulation (EU) 1272/2008).

Classification for respiratory irritation:

Based on irritating effects observed in an acute inhalation study the substance has to be labelled as STOT single cat 3 "May cause respiratory irritation" due to criteria of GHS (Regulation (EU) 1272/2008).

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