Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
other: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test substance: N-Methyldiisopropanolamin
Test-substance No.: 11/0383-1
Batch identification: B 5614 vom 21.12.2010
CAS No.: 4402-30-6
Purity: 99.7 corr. area-% (for details see project No.: 11L00331)
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period
was guaranteed by the sponsor, and the sponsor holds this
responsibility.

Test animals

Species:
other: human-derived epidermal keratinocytes

Test system

Controls:
other: positive and negative controls
Duration of treatment / exposure:
3 and 60 min

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: corrosion
Basis:
other: mean OD50
Time point:
other: 3 min
Score:
74
Remarks on result:
other: viability [% of NC]
Irritation parameter:
other: corrosion
Basis:
other: mean OD50
Time point:
other: 1 hour
Score:
11
Remarks on result:
other: viability [% of NC]
Irritation parameter:
other: irritation
Basis:
other: mean OD50
Time point:
other: 1 hour
Score:
6
Remarks on result:
other: viability [% of NC]

Any other information on results incl. tables

Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with highly de-ionized water. A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥ 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.

Although the method is not finally validated for categorizing the severity of corrosivity according to certain classification and labeling systems, it is suggested to use the most stringent category for test substances leading to viabilities below 50% after 3 min treatment. Irritant potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.

Applicant's summary and conclusion

Conclusions:
Based on the observed results and applying the evaluation criteria it was concluded, that N-Methyldiisopropanolamin shows a corrosive potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
Executive summary:

Corrosion test:

The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 74%, and it was 11% after an exposure period of 1 hour.

Irritation test:

The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 6%.