Registration Dossier

Diss Factsheets

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
Reference
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
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.

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.

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.

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.

Categories Display