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Toxicological information

Eye irritation

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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:
2020
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

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:
Phenol, isopropylated
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

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.

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