Registration Dossier

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)