Registration Dossier
Registration Dossier
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EC number: 291-826-2 | CAS number: 90480-88-9
Endpoint summary
Administrative data
Description of key information
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 and Eye Irritation is assessed in this manner. Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Calculation method
- 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. - Qualifier:
- no guideline required
- 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 system:
- other: Not applicable - Calculation method
- Source species:
- other: Not applicable - Calculation method
- Cell type:
- other: Not applicable - Calculation method
- Cell source:
- other: Not applicable - Calculation method
- Source strain:
- other: Not applicable - Calculation method
- Details on animal used as source of test system:
- Not applicable - Calculation method
- Justification for test system used:
- 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.
- Vehicle:
- other: Not applicable - Calculation method
- Details on test system:
- Not applicable - Calculation method
- Control samples:
- not required
- Amount/concentration applied:
- Not applicable - Calculation method
- Duration of treatment / exposure:
- Not applicable - Calculation method
- Duration of post-treatment incubation (if applicable):
- Not applicable - Calculation method
- Number of replicates:
- Not applicable - Calculation method
- Species:
- other: Not applicable - Calculation method
- Strain:
- other: Not applicable - Calculation method
- Details on test animals or test system and environmental conditions:
- Not applicable - Calculation method
- Type of coverage:
- other: Not applicable - Calculation method
- Preparation of test site:
- other: Not applicable - Calculation method
- 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:
- Not applicable - Calculation method
- Number of animals:
- Not applicable - Calculation method
- Details on study design:
- Not applicable - Calculation method
- Irritation / corrosion parameter:
- other: Calculation method
- Run / experiment:
- Not applicable - see below
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- On the basis of calculation in accordance with CLP Table 3.2.3, H314: Causes severe skin burns and eye damage is applicable.
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- On the basis of calculation in accordance with CLP Table 3.2.3, H314: Causes severe skin burns and eye damage is applicable.
- Executive summary:
On the basis of calculation in accordance with CLP Table 3.2.3, H314: Causes severe skin burns and eye damage is applicable.
Reference
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) |
H315: Causes skin irritation. |
disoprofol EC no.: 218-206-6 |
12 % (w/w) |
H315: Causes skin irritation. |
2,5-diisopropylphenol EC no.: 252-807-4 |
10 % (w/w) |
H315: Causes skin irritation. |
3-isopropylhydroxybenzene EC no.: 210-551-0 |
10 % (w/w) |
H315: Causes skin irritation. |
By reference to CLP Table 3.2.3:
|
Applied C&L |
|
Classify as Skin Corr 1 when the sum concentration of ingredients classified as such is ≥ 5%. The total of Skin Corr 1 ingredients is 85%, therefore is classified as Skin Corr 1 because the concentration is > 5%. Effects of Skin Cat 2 can be disregarded. |
H314: Causes severe skin burns and eye damage. |
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- 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. - 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
- 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
- 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.
- 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.
- 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.
Reference
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. |
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
On the basis of calculation in accordance with CLP, 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
