Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation, other
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Study period:
January 2020
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
K2 is assigned as results are based on calculation of effects based on components.
CLP classification is available for the individual components of the substance via REACH Annex VI harmonised classifications, REACH Registration dossiers or notifications to the CLP inventory. As such, it is deemed inappropriate to conduct additional testing on the reaction mass subject to this registration when the results may be predicted on the basis of the components themselves. Skin Sensitisation is assessed in this manner. Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.

Data source

Reference
Reference Type:
other: Calculation method
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
(EC) No 1907/2006 Regulation on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 and its amendments

Calculation of ATEMix utilising (EC) No 1907/2006 Regulation on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 and its amendments. The highest concentration in the composition range for each substance was utilised for the purposes of the assessment.
GLP compliance:
no
Justification for non-LLNA method:
CLP classification is available for the individual components of the substance via REACH Annex VI harmonised classifications, REACH Registration dossiers or notifications to the CLP inventory. As such, it is deemed inappropriate to conduct additional testing on the reaction mass subject to this registration when the results may be predicted on the basis of the components themselves. Skin Sensitisation is assessed in this manner. Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenol, isopropylated
EC Number:
291-826-2
EC Name:
Phenol, isopropylated
Cas Number:
90480-88-9
Molecular formula:
see reference substances connected to main constituents in Section 1.2
IUPAC Name:
2,4-bis(propan-2-yl)phenol; 2-(propan-2-yl)phenol; 4-(propan-2-yl)phenol; phenol
Test material form:
liquid
Details on test material:
Identification: ISO-MIX
Batch (Lot) Number: A00000987
Expiry date: 13 June 2020 (retest date)
Physical Description: Clear colourless to yellow liquid
Storage Conditions: At room temperature

Additional information
Test Facility test item number: 210424/A
Purity/Composition correction factor: No correction factor required
Test item handling: No specific handling conditions required
Chemical name (IUPAC, synonym or trade name): Reaction mass of 2,4-diisopropylphenol and 2-isopropylphenol and p-isopropylphenol andphenol (Phenol, isopropylated)
CAS number: 90480-88-9
EINECS number: 291-826-2

In vivo test system

Test animals

Species:
other: Not applicable - Calculation method
Strain:
other: Not applicable - Calculation method
Sex:
not specified
Details on test animals and environmental conditions:
Not applicable - Calculation method

Results and discussion

Positive control results:
Not applicable - Calculation method

In vitro / in chemico

Results
Key result
Run / experiment:
other: Not applicable - Calculation method
Parameter:
other: Calculation of skin sensitisation potential
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no indication of skin sensitisation
Remarks:
On the basis of calculation. See below

In vivo (LLNA)

Cellular proliferation data / Observations:
Not applicable - Calculation method

Any other information on results incl. tables

No components are classified for skin sensitisation, hence this endpoint is "Not Classified". Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No components are classified for skin sensitisation, hence this endpoint is "Not Classified". Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.
Executive summary:

No components are classified for skin sensitisation, hence this endpoint is "Not Classified".Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.