Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Propane-1,2-diol, propoxylated
EC Number:
500-039-8
EC Name:
Propane-1,2-diol, propoxylated
Cas Number:
25322-69-4
Molecular formula:
(C3 H6 O)n H2 O n= >1 - <4.5
IUPAC Name:
propylene glycol
Details on test material:
Name: Propane-1,2-diol propoxylated
Molecular weight: Mn = 260 g/mole
Physical state: pale yellow liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS: Rabbit
- Strain: New Zealand White
- Sex: male/female
- Source: Hazleton Research Products, Denver
- Age: 8-12 weeks
- Weight at study initiation: 2.486-2.802 kg
- Number of animals: 6
- Controls: Untreated skin

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted (0.5 ml)
Duration of treatment / exposure:
3 minutes, 60 minutes, 4 hours and 24 hours
Number of animals:
6
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: undiluted
- Area of exposure: 6 cm2
- Occlusion: Semi-occluded
- Total volume applied: 0.5 ml to intact (all time period) and abraded (24 hours only) skin
- Exposure time: 3 minutes, 1, 4 and 24 hours
- Postexposure period: 72 hours post patch removal
- Removal of test substance: water and gauze

EXAMINATIONS
- Scoring system: Draize
- Examination time points: 3 minutes, 1, 4, 24, 48 and 72 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4 hour
Score:
0.13
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: according to Draize, max. score for both erythema and edema is 4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hour exposure
Score:
0.04
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: according to Draize, max. score for both erythema and edema is 4
Other effects:
Immediately after patch removal there were no effects after 3 minute exposure, slight erythema (grade 1) in 2/6 rabbits after 1 hour, 3/6 after 4 hours and 1/6 after 24 hour exposure.
REVERSIBILITY: Complete

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This propoxylated propane-1,2-diol (molecular weight 230) was considered not irritating according to EU GHS.