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Description of key information

Key in vitro skin irritation and skin corrosion studies showed that the test item was neither irritating nor corrosive under the conditions of the tests. 
In vivo eye irritation study was not conducted according to Regulation (EC) No 1906/2007, Annex VIII, Section 8.2.1 Column 2. The substance is classified as irritating to eyes with risk of serious damage to eyes in line with structurally similar alkylsulfates and alkylethersulfates to avoid testing of vertebrate animals.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012 - 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study in accordance with EU method B.40.
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test material (as cited in study report): DE07_2012_001_PLSW
- Substance type: Alkylsulfate/alkylethersulfate
- Chemical name: Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts
- CAS: n/a
- Physical state: ivory paste-like solid at 20 °C
- Batch No.: PU20740016, PU20740019
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
water
Type of coverage:
occlusive
Preparation of test site:
other: EpiDermTM
Vehicle:
water
Amount / concentration applied:
approx. 25 mg + 15 μL H2O
Duration of treatment / exposure:
3 min and 60 min experiments
3 h postincubation period
Details on study design:
This in vitro method is designed to predict and classify the skin corrosivity potential of a chemical by assessment of its effect on EpiDerm, a
reconstituted three-dimensional human epidermis model. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min. and 60 min. exposure period. The EpiDerm Skin Model is a well established organotypic, threedimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin. This in vitromethod allows the identification of corrosive chemical substances and mixtures. It further allows the identification of noncorrosive substances and mixtures when supported by a weight of evidence determination using non-animal methods.
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 tissues per dose group
Run / experiment:
negative control
Value:
100
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Remarks:
3 min exposure and 3 h of post-incubation
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 tissues per dose group
Run / experiment:
positive control
Value:
12
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Remarks:
3 min exposure and 3 h of post-incubation
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 tissues per dose group
Run / experiment:
test item
Value:
92
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Remarks:
3 min exposure and 3 h of post-incubation
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 tissues per dose group
Run / experiment:
negative control
Value:
100
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Remarks:
60 min exposure and 3 h of post-incubation
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 tissues per dose group
Run / experiment:
positive control
Value:
10
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Remarks:
60 min exposure and 3 h of post-incubation
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 tissues per dose group
Run / experiment:
test item
Value:
100
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Remarks:
60 min exposure and 3 h of post-incubation
Irritant / corrosive response data:
not applicable

Pre-Experiment:

The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. The mixture of 25 mg test item per 300 μL A. dest. showed no colouring as compared to the solvent.

Experiment:

3 min:

Total mean OD550 of 2 replicate tissues (blank-corrected)

Negative Control: 2.667

Positive Control: 0.330

Test Item: 2.463

SD (OD550)

Negative Control: 0.300 / 0.028

Positive Control: 0.007 / 0.004

Test Item: 0.030 / 0.036

Mean relative tissue viabilities [%]

Negative Control

100

Positive Control

12

Test Item

92

60 min:

Total mean OD550 of 2 replicate tissues (blank-corrected)

Negative Control: 2.671

Positive Control: 0.259

Test Item: 2.667

SD OD550

Negative Control: 0.498 / 0.036

Positive Control: 0.005 / 0.003

Test Item: 0.105 / 0.038

Mean relative tissue viabilities [%]

Negative Control

100

Positive Control

10

Test Item

100

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
Executive summary:

The potential of the test item to induce skin corrosion was analysed by using the three-dimensional human skin model EpiDerm, comprising a reconstructed epidermis with a functional stratum corneum. In the present study the test item was applied topically to the EpiDerm tissue for 3 min. and 60 min. followed by immediate determination of cytotoxic effects via MTT reduction assay. Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods compared to the corresponding negative control tissues concurrently treated with dest. water. The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was >= 50% (92%) after 3 min. treatment and >= 15% (100%) after 60 min. treatment.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

It is generally agreed that the EU B.46 (OECD 439) in vitro method for skin irritation represent a full replacement of the respective in vivo method (OECD 404) in a tiered testing strategy and in conjunction with in vitro skin corrosivity tests (Reference: Evaluation under REACH, Progress Report 2010). Both in vitro methods for skin irritation and skin corrosion in accordance with OECD testing guidelines were conducted and showed no positive results. The available data indicates that the criteria for classification as corrosive or irritant (EU GHS) for the skin is not met. Consequently classification of the test item is not required.


Justification for selection of skin irritation / corrosion endpoint:
In a OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test) and a OECD Guideline 439 (In Vitro Skin Irritation) study no skin corrosive or skin irritating effects were observed under the conditions of the tests.

Justification for selection of eye irritation endpoint:
The study does not need to be conducted according to Regulation (EC) No 1906/2007, Annex VIII, Section 8.2.1 Column 2. The substance is classified as irritating to eyes with risk of serious damage to eyes in line with similar alkylsulfates and alkylethersulfates to avoid testing of vertebrate animals.

Effects on eye irritation: irritating

Justification for classification or non-classification

The test item is not classified as irritating to the skin according to the CLP regulation (EC) No 1272/2008 based on Klimisch 1 GLP in vitro skin irritation and skin corrosion studies. The substance is classified as irritating to eyes with risk of serious damage to eyes in line with structurally similar alkylsulfates and alkylethersulfates to avoid testing of vertebrate animals. According to CLP regulation (EC) No 1272/2008, Category 1 classification is proposed with signal word 'Danger' and hazard statement H318 'Causes serious eye damage'.

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