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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
A mixture of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
EC Number:
413-750-2
EC Name:
A mixture of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
IUPAC Name:
413-750-2
Constituent 2
Reference substance name:
reaction mass of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
IUPAC Name:
reaction mass of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
other: 72 h
Max. score:
1
Reversibility:
no data
Remarks on result:
other: Max. duration: 1 d; Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal: all
Time point:
other: 72 h
Max. score:
0
Reversibility:
no data
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
The test substance, when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered as non irritant for the skin.
Executive summary:

The structural analogue was found to be not irritating to rabbit skin in a GLP study according to EU Method B.4. Since EC 700-397-7 is a near analogue to the test substance (EC 413-750-2), the experimental data from this substance were used in a read-across approach.