Registration Dossier

Administrative data

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:
other: Modern OECD-guideline study performed under GLP-conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 431 and 439
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: reconstructed human epidermal model EpiDerm

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
irritation test: 1 h plus 42 hrs post treatment incubation
corrosion test: 3 min and 1 h, respectively

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: viability
Value:
23
Remarks on result:
other:
Remarks:
Basis: mean. Time point: after post-treatment. Remarks: irritation test. (migrated information)
Irritation / corrosion parameter:
other: other: viability
Value:
33
Remarks on result:
other:
Remarks:
Basis: mean. Time point: after 1 h exposure. Remarks: corrosion test. (migrated information)

Any other information on results incl. tables

irritation test
  exposure 1 h plus 42 hrs post-treatment incubation 
viability (% negative control) 23
corrosion test
exposure: 3 min exposure: 1 h
viability (% negative control) 72  33 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Based on the observed results and applying the evaluation criteria it was concluded, that 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane shows a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
Executive summary:

The potential of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane to cause dermalcorrosion/irritation was assessed by a single topical application of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.