Registration Dossier
Registration Dossier
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EC number: 291-826-2 | CAS number: 90480-88-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation, 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 Irritation 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:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 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
Test material
- 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
Constituent 1
Test animals / tissue source
- Species:
- other: Not applicable - Calculation method
- Strain:
- other: Not applicable - Calculation method
- Details on test animals or tissues and environmental conditions:
- Not applicable - Calculation method
Test system
- Vehicle:
- other: Not applicable - Calculation method
- Controls:
- not required
- Amount / concentration applied:
- Not applicable - Calculation method
- Duration of treatment / exposure:
- Not applicable - Calculation method
- Observation period (in vivo):
- Not applicable - Calculation method
- Duration of post- treatment incubation (in vitro):
- Not applicable - Calculation method
- Number of animals or in vitro replicates:
- Not applicable - Calculation method
- Details on study design:
- 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.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Calculation method
- Run / experiment:
- Not applicable - Calculation method
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Remarks:
- Classified as Corrosive by calculation. See below
- Other effects / acceptance of results:
- On the basis of calculation in accordance with CLP Table 3.3.3, H314: Causes severe skin burns and eye damage is applicable.
Any other information on results incl. tables
The following components were used for the calculation:
Chemical name |
Concentration(%) |
C&L |
2-isopropylphenol EC no.: 201-852-8 |
35 % (w/w) |
H314: Causes severe skin burns and eye damage. |
Phenol EC no.: 203-632-7 |
30 % (w/w) |
H314: Causes severe skin burns and eye damage. |
p-isopropylphenol EC no.: 202-798-8 |
20 % (w/w) |
H314: Causes severe skin burns and eye damage. |
2,4-diisopropylphenol EC no.: 220-906-1 |
20 % (w/w) |
H319: Causes serious eye irritation |
disoprofol EC no.: 218-206-6 |
12 % (w/w) |
H319: Causes serious eye irritation |
2,5-diisopropylphenol EC no.: 252-807-4 |
10 % (w/w) |
H319: Causes serious eye irritation |
3-isopropylhydroxybenzene EC no.: 210-551-0 |
10 % (w/w) |
H319: Causes serious eye irritation |
By reference to CLP Table 3.3.3:
|
Applied C&L |
|
Classify as Eye Dam 1 if the sum concentration of ingredients classified as Eye Dam 1 or Skin Corr 1A, 1B, 1C is ≥ 3 %. The total concentration of ingredients classified as such is 85%%. therefore is classified as Eye Dam 1 because the concentration is >3%. Effects of Eye Cat 2 can be disregarded |
H314: Causes severe skin burns and eye damage. |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- On the basis of calculation in accordance with CLP Table 3.3.3, H314: Causes severe skin burns and eye damage is applicable.
- Executive summary:
On the basis of calculation in accordance with CLP Table 3.3.3, H314: Causes severe skin burns and eye damage is applicable.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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