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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: FHSLA procedure
GLP compliance:
not specified
Species:
rabbit
Strain:
other: albino
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
other: see below
Amount / concentration applied:
0.5 ml test solution on the patch.
Concentrations of the test substance in the test solution were 4, 8 and 16% in petrolatum, respectively dimethyl phthalate
Duration of treatment / exposure:
24 h
Observation period:
24h and 48h (immediately after patch removal and 24 hours after patch removal)
Number of animals:
6
Details on study design:
Scoring according to Draize
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
8
Reversibility:
other: not applicable (no effects seen)
Remarks on result:
other: application of upto a concentration of 16% of the test substance in petrolatum
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h
Score:
0.25
Max. score:
8
Reversibility:
fully reversible within: another 24 h
Remarks on result:
other: application of upto a concentration of 16% of the test substance in dimethyl phthalate. Effect was only seen at 16%, not at 4% or 8%
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Draize
GLP compliance:
not specified
Species:
rabbit
Strain:
other: albino
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of same animal
Amount / concentration applied:
100 mg of the undiluted substance
Duration of treatment / exposure:
there was no eye wash
Observation period (in vivo):
daily for 7 days
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 1
Score:
20
Max. score:
110
Remarks on result:
other: In a second identical study the score was 17
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 2
Score:
7
Max. score:
110
Remarks on result:
other: In a second identical study the score was 15
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 3
Score:
0
Max. score:
110
Remarks on result:
other: In a second identical study the score was 10.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 4
Score:
0
Max. score:
110
Remarks on result:
other: In a second identical study the score was 3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 5
Score:
0
Max. score:
110
Remarks on result:
other: In a second identical study the score was 0
Interpretation of results:
Category 2B (mildly irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

In view of the experimental results (OECD 405) the substance must be classified for eye irritation category 2 with H319 (causes serious eye irritation)