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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
Study period:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test material was applied undiluted to the ear, and shaven intact and abraded skin of white rabbits. The intact and abraded areas are covered with a cotton patch then bandaged to hold the material in constant contact with the skin. Each working day fresh material was applied. In this study 2 applications were conducted.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material: Ethylene glycol n-propyl ether
Source: Ethylene Research Laboratory, The Dow Chemical Company

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
Body weight 2.68 kg

Test system

Type of coverage:
other: Ear- open, belly- intact and abraded skin both covered
Preparation of test site:
other: shaved , intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
No data
Duration of treatment / exposure:
2 single applications to the ear and belly (intact and abraded)
Observation period:
Typically up to 1 week after completing the applications.
Number of animals:
1
Details on study design:
The test material was applied undiluted to the ear, and shaven intact and abraded skin of white rabbits. The intact and abraded areas are covered with a cotton patch then bandaged to hold the material in constant contact with the skin. Each working day fresh material was applied. In this study 2 applications were conducted.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 hour
Score:
1
Max. score:
6
Remarks on result:
other: Score for ear and belly (intact and abraded)
Irritation parameter:
other: hyperemia
Basis:
animal #1
Time point:
other: 24 hour
Score:
1
Max. score:
6
Remarks on result:
other: Ear
Irritation parameter:
other: hyperemia
Basis:
animal #1
Time point:
other: 24 hour
Score:
2
Max. score:
6
Remarks on result:
other: Belly (intact and abraded)
Irritation parameter:
other: necrosis
Basis:
animal #1
Time point:
other: 24 hour
Score:
1
Max. score:
6
Remarks on result:
other: Ear
Irritation parameter:
other: necrosis
Basis:
animal #1
Time point:
other: 24 hour
Score:
2
Max. score:
6
Remarks on result:
other: Belly (intact and abraded)
Irritation parameter:
other: exfoliation
Basis:
animal #1
Time point:
other: 24 hour
Score:
2
Max. score:
6
Remarks on result:
other: Ear
Irritation parameter:
other: exfoliation
Basis:
animal #1
Time point:
other: 24 hour
Score:
1
Max. score:
6
Remarks on result:
other: Belly (intact and abraded)
Irritation parameter:
other: scab and scar
Basis:
animal #1
Time point:
other: 24 hour
Score:
2
Max. score:
6
Remarks on result:
other: Belly (abraded)
Irritant / corrosive response data:
No irritation was observed on the ear or belly (intact and abraded).
Other effects:
The rabbit died after the second application, probably due to systemic injury as a result of absorption through the skin. Observations consisting of bloody urine and burned-dark green were noted. Animal appeared to be a bit nervous.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: other: EU GHS
Conclusions:
The material should present no problem from skin irritation as a result of a single prolonged exposure to either intact or abraded skin. However, range finding tests indicate that the material is absorbed through the skin and is capable of producing serious internal injury. According to the EU CLP regulations (GHS Criteria), the substance would be not be classified.
Executive summary:

2 single applications of Ethylene glycol n-propyl ether to the ear and belly (intact and abraded) of rabbit were evaluated and no irritation was observed on the ear or belly (intact and abraded). According to the EU CLP regulations (GHS Criteria), the substance would be not be classified.