Registration Dossier
Registration Dossier
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EC number: 273-381-6 | CAS number: 68958-92-9
Endpoint summary
Administrative data
Description of key information
In the in vitro tests for skin irritation/corrosion (OECD 439/OECD431) and eye irritation (OECD 437 and OECD 492) no effects were observed.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 BIS (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- May 2008 (REG (EC) No. 440/2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- validated in vitro test model for sequential testing strategy
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- see attached documents "S-930 - Skin corrosion Study Design.pdf"
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): undiluted
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 8N KOH - Duration of treatment / exposure:
- 3 min and 1 hour
- Number of replicates:
- 4 (two for the 3-minute exposure and two for the 1-hour exposure)
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3-min exposure
- Value:
- 93
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 1-h exposure
- Value:
- 92
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- no classification according to REGULATION (EC) 1272/2008
- Endpoint:
- skin irritation: in vitro / ex 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- July 2012 (REG (EC) No. 440/2008 amended by REG (EC) No. 640/2012)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- validated in vitro test model for sequential testing strategy
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- see attached documents "S-930 - Skin irritation Study Design.pdf"
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µL
- Concentration (if solution): undiluted
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL
- Concentration (if solution): neat
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL
- Concentration (if solution): 5% SDS in PBS - Duration of treatment / exposure:
- 15 ± 0.5 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 89
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- no classification according to REGULATION (EC) 1272/2008
Referenceopen allclose all
for detailed results see attached document "S-930 - Skin corrosion Results.pdf"
for detailed results see attached document "S-930 - Skin irritation Results.pdf"
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 10 ± 1 minutes
- Duration of post- treatment incubation (in vitro):
- 120 ± 10 minutes
- Number of animals or in vitro replicates:
- 3 corneas
- Details on study design:
- see attached documents "S-930 - Eye irritation (BCOP) Study Design.pdf"
- Irritation parameter:
- in vitro irritation score
- Value:
- 5.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no prediction can be made
- Irritation parameter:
- cornea opacity score
- Value:
- 2.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein leakage
- Value:
- 0.206
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Since S-930 induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Since S-930 induced an IVIS > 3 ≤ 55, the study cannot be used for classification. An EpiOcular™ Cornea Epithelial Model assay was performed.
- Endpoint:
- eye irritation: in vitro / ex 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- October 2017
- Deviations:
- yes
- Remarks:
- Slight deviations from incubation times (pre- and post-treatment) are not considered to have affected the overall integrity of the study or the interpretation of the study results and conclusions since both controls fulfilled the acceptability criteria.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 30 ± 2 minutes
- Duration of post- treatment incubation (in vitro):
- 120 ± 15 minutes
- Number of animals or in vitro replicates:
- 2 tissues
- Details on study design:
- see attached documents "S-930 - Eye irritation (EpiOcular) Study Design.pdf"
- Irritation parameter:
- other: mean % tissue viability
- Value:
- 110
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- no classification according to REGULATION (EC) 1272/2008
Referenceopen allclose all
for detailed results see attached document "S-930 - Eye irritation (BCOP) Results.pdf"
for detailed results see attached document "S-930 - Eye irritation (EpiOcular) Results.pdf"
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In the in vitro skin irritation/corrosion and eye irritation tests no adverse effects were obsserved. No classification according to REGULATION (EC) 1272/2008.
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