Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating 
Eye irritation (OECD 405): not irritating

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study (non-GLP).
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Occlusive dressing.
GLP compliance:
no
Species:
rabbit
Strain:
other: Kleine weiße Russen
Details on test animals and environmental conditions:
According to Guideline.
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Kleine weiße Russen (Chbb-SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: No data
- Weight at study initiation: 2.3-2.5 kg
- Housing: Individually
- Diet: K4 Alleindiät für Kaninchen (Ssniff Spezialfutter GmbH, Soest, Germany); ad libitum
- Water: Tap water; ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72 h
Observation period (in vivo):
6 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With lukewarm physiological NaCl solution
- Time after start of exposure: 72 h after application

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A voluntary industry programme to carry out Human and Environmental Risk Assessments on ingredients of household cleaning products (HERA) evaluated the irritation potential of AEs. According to HERA the irritation potential is decreasing with increasing ethoxylation degree. The lower ethoxylation level of EO 1 - 3, which includes all substances of the category, appeared to be more irritating (HERA, 2009). Since the category chemicals differ mainly from each other only by the number of -CH2- units (except for the unsaturated group), the category is very homogenous and it is assumed that each category member exhibits the same toxic mode of action.

Based on weight of evidence and interpolation on the given study reports the following subcategories for skin irritation can be derived:

Class I:          short chain AEO (C6-11) → not classified for skin irritation 

Class II:         detergent grade AEO (C12-15) → not classified for skin irritation

Class III:        saturated long chain AEO (C16-18) → not classified for skin irritation

Class IV:        unsaturated long chain AEO (C16/18 and C18 unsatd.) → R38 / H315

For further details please refer to the category justification. Exemplary study summaries are provided for the skin and eye irritating potential of C16-18 AE.

A study according to OECD Guideline 404 with C16-18AE (CAS 68439-49-6) assessed the irritating potential to the skin. Three albino rabbits were exposed for 4 h to 0.5 mL test substance under occlusive conditions and observed for subsequent 14 days. Mean erythema and oedema scores over all animals within three days were 0.3 and 0, respectively. Erythema was fully reversible.

 

To investigate the eye irritating potential, a study with C16-18 (CAS 68439-49-6) was conducted according to OECD Guideline 405. Three rabbits were treated with 0.1 mL of undiluted test substance for 72 h until the exposed eyes were washed with lukewarm physiological sodium chloride solution. No irritating effects were noted.

Regarding eye irritation, the test substance does not meet the criteria for classification according to 67/548/EEC and Regulation 1272/2008. This result is in line with the outcome of a trend analysis performed for eye irritating properties of the members of the AE Category to evaluate the impact of carbon chain length distribution on the eye irritating properties. All available studies, performed according to OECD Guideline 405 under GLP conditions, applying AE of a high purity (>95%) and an ethoxylation degree ≤ 2.5 and allowing the evaluation of the recovery (until day 21), were evaluated. According to this evaluation AE of the AE Category having a carbon chain length ≥ C12 do not need to be classified for eye irritation/severe eye irritation. Based on this analysis C16-18 AE (CAS 68439-49-6) is not classified for eye irritation. For further information please refer to the category justification.

 


Justification for selection of skin irritation / corrosion endpoint:
Reliable Guideline study chosen.

Justification for selection of eye irritation endpoint:
Reliable Guideline study chosen.

Justification for classification or non-classification

According to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the test substance does not need to be classified for skin and eye irritation.