Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
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. Acute oral toxicity 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 type:
other: Calculation method.
Limit test:
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

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

Administration / exposure

Route of administration:
other: Not applicable - Calculation method
Vehicle:
other: Not applicable - Calculation method
Details on oral exposure:
Not applicable - Calculation method
Doses:
Not applicable - Calculation method
No. of animals per sex per dose:
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

Results and discussion

Preliminary study:
Not applicable - Calculation method
Effect levels
Key result
Sex:
not specified
Dose descriptor:
other: Acute Toxicity Estimate
Effect level:
230.41 mg/kg bw
Based on:
other: Acute Toxicity Estimate
Remarks on result:
other: Calculation method
Mortality:
Not applicable - Calculation method
Clinical signs:
Not applicable - Calculation method
Body weight:
Not applicable - Calculation method
Gross pathology:
Not applicable - Calculation method
Other findings:
Not applicable - Calculation method

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)

H302: Harmful if swallowed.

Phenol EC no.: 203-632-7

30 % (w/w)

H301: Toxic if swallowed.

p-isopropylphenol EC no.: 202-798-8

20 % (w/w)

H302: Harmful if swallowed

disoprofol EC no.: 218-206-6

12 % (w/w)

H302: Harmful if swallowed.

 

And classification derived on the basis of ATEMix from CLP, where ATEi is taken from CLP Regulation Table 3.1.2

Calculations are therefore;

Substance

Conc

ATEi

Calc

2-isopropylphenol EC no.: 201-852-8

35

500

0.07

Phenol EC no.: 203-632-7

30

100

0.30

p-isopropylphenol EC no.: 202-798-8

20

500

0.04

disoprofol EC no.: 218-206-6

12

500

0.02

Total

0.43

Therefore ATEmix =

230.41

 

On the basis of CLP, Table 3.1.1,H301: Toxic if swallowed is applied.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
On the basis of the calculation approach, an ATEmix of 230.41 mg/kg was derived. H301: Toxic if swallowed is applicable.
Executive summary:

On the basis of the calculation approach, an ATEmix of 230.41 mg/kg was derived.  H301: Toxic if swallowed is applicable.       

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