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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted prior to GLP and guidelines. The report contains sufficient amount of data for the interpretation of the results. Non-GLP studyequivalent to OECD guideline 404. Quality Check: This study was performed prior to establishment of GLPs or publication of protocol guidelines. The report included very limited documentation for methods and results but the performing institution, Carnegie Mellon, was/is highly regarded. As typical for a study this old, the report did not provide sufficient documentation that elements of OECD Protocol 404: "Acute Dermal Irritation/Corrosion" were followed, although the numbers and type of test animals used (but not their husbandry conditions) were as recommended in the guidance. Remarkably, the length of time that test material was held in contact with the skin was not defined. Test material characterization was not addressed other than to identify batch numbers, amount received, and receipt dates. While the length of the observation period was not explicitly stated it is presumed to have been the typical 14 days or until all signs of irritation had regressed; the toxicity endpoints monitored were typical for this type assay and adequately recorded.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[2-(2-methoxymethylethoxy)methylethoxy]propanol
EC Number:
247-045-4
EC Name:
[2-(2-methoxymethylethoxy)methylethoxy]propanol
Cas Number:
25498-49-1
Molecular formula:
C10H22O4
IUPAC Name:
[2-(2-Methoxymethylethoxy)methylethoxy]propanol
Details on test material:
Propasol Solvent TM
Amount Received: 1 pint
Sample No. 40-130
ID: 511-01-1485
Receipt Date: March 22, 1977

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
open
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.010ml



Duration of treatment / exposure:
24 hour(s)
Observation period:
14 days
Number of animals:
5

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours to 14 days
Score:
1
Max. score:
10
Reversibility:
other: no irritation effects observed
Irritant / corrosive response data:
no injury is judged to be a grade 1.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tripropylene glycol methyl ether (TPM) does not appear to be irritating to the skin of rabbits under the conditions of this test.
Classification: not irritating
Executive summary:

Tripropylene glycol methyl ether (TPM) was tested for skin irritation in albino rabbits. 3 to 5 old male rabbits were used. TPM was applied to the intact clipped skin of the belly of 5 albino rabbits for an unspecified period of time. The application site was not covered and, presumably, subjects were restrained to prevent grooming and consequent ingestion (subjects were restrained in the dermal LD50 test by the same institution, described above, on this same batch of test material). Irritation was scored on a scale of 1 to 10, based on moderate or marked capillary injection, erythema, edema or necrosis within 24 hours. While the length of the observation period was not explicitly stated it is presumed to have been the typical 14 days or until all signs of irritation had regressed; the toxicity endpoints monitored were typical for this type assay and adequately recorded. No evident injury is judged to be a Grade 1.