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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study that meets accepted scientific standard, well document and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test was prformed according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Labelling Act Sect. 191.11 (February 1965).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2,3-epoxypropyl) terephthalate
EC Number:
230-565-0
EC Name:
Bis(2,3-epoxypropyl) terephthalate
Cas Number:
7195-44-0
Molecular formula:
C14H14O6
IUPAC Name:
1,4-bis[(oxiran-2-yl)methyl] benzene-1,4-dicarboxylate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Healthy New Zealand White rabbits aged 12 - 16 weeks with average body weights of 2.93 kgs for the males and 2.80 kgs for the females, bred on the premises and maintained under semi-barrier system. The animals were acclimatized in the test area for one week prior to the start of the trial.
Experimental room was maintained at a temperature of 20C and a relative humidity of 50-70%. Light cycle of 10 Hours / 14 hours per day. A commercial irradiated diet was fed ad lib. and filtered sterile water was available at all times.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: one site shaved and one site abraded
Vehicle:
other: 2% aqueous solution of carboxymethyl cellulose
Controls:
no
Amount / concentration applied:
1.0 mL of of the test substance in suspension at a concentration of 0.5g/mL was applied
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square gau
- Type of wrap if used: The gauze was covered with aluminium foil secured with "seek" adhesive tape (Smith and Nephew, Hull, England). The test site was then covered by a 6" wide "coban" self adhesive bandage (3M Company, London).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing done
- Time after start of exposure: 24 hours

SCORING SYSTEM:
Erythema and eschar formation:
No erythema ......................................................................... .Grade 0
Slight eryhtema (barely perceptible) ..................................Grade 1
Well defined erythema............................................................Grade 2
Moderate to severe.................................................................Grade 3
Severe erythema (beet red) to slight eschar formation... Grade 4

Oedema formation:
No oedema.....................................................................................................................................Grade 0
Very slight oedema (barely perceptible)....................................................................................Grade 1
Slight oedema (edges or area well defined by definite raising)..............................................Grade 2
Moderate oedema (raised approximately 1 mm)......................................................................Grade 3
Severe oedema (raised more than 1mm and extending beyond the area of exposure).....Grade 4

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24-hour and 72-hour readings
Score:
0.7
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact and abraded sites were taken into consideration
Irritant / corrosive response data:
Slight erythema was seen on 3/6 intact and 6/6 abraded sites and very slight to slight oedema on 2/6 intact and 5/6 abraded sites.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The substance is a slight primary skin irritant in the albino rabbit.
Executive summary:

The primary skin irritation potential of the substance was investigated by occlusive application to intact and abraded skin of six New Zealand White rabbits. The substance was applied at a concentration of 0.5 g/mL and a volume of 1.0 mL per application site. The duration of treatment was 24 hours. The scoring of the reaction 24 hours and 72 hours after treatment start.

The mean score was calculated across two scoring times (24 and 72 hours) for each animal for erythema and oedema.

The application of the test substance to the skin resulted in slight erythema on 3/6 intact and 6/6 abraded sites and very slight to slight oedema on 2/6 intact and 5/6 abraded sites.

The substance is considered to be a slight primary skin irritant in the albino rabbit.