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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:
1990-03-29 to 1990-04-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Proprietary study, similar to current OECD guidelines.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Isophthalic acid
EC Number:
204-506-4
EC Name:
Isophthalic acid
Cas Number:
121-91-5
Molecular formula:
C8H6O4
IUPAC Name:
isophthalic acid
Details on test material:
- Name of test material (as cited in study report): isophthalic acid
- Physical state: White powder
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The animals were New Zealand White rabbits (of either sex), purchased from Johnson Rabbit Ranch. Rabbits weighed approximately 2.0-3.5 kg on arrival. Rabbits were housed individually in stainless steel suspended cages. Each rabbit was given approximately 150 g of Purina Lab Rabbit Chow HF #5326. Reverse-osmosis purified water was provided ad libitum. Individuals were identified by metal ear tags. The temperature and relative humidity of the animal rooms was monitored, and fluorescent lighting was provided on a 12 hour light/dark cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 g test material was applied undiluted to the back's of the rabbits. Individual doses were weighed onto aluminium foil.
Duration of treatment / exposure:
4 hours exposure
Observation period:
72 hours
Number of animals:
Three
Details on study design:
Rabbits were selected at random. Prior to study initiation, the backs of all candidate test animals were shaved and examined for abnormalities. Animals with significant skin abnormalities were not used in the study.
Approximately 24 hours prior to testing, fur from the trunk of the animals was clipped so that no less than 10% of the dorsal body surface area was available for application. A 0.5 g dose was applied, and the treated site covered by a 2.5 cm³ adhesive dressing (Coverlet). The entire midsection of the rabbit was wrapped in a lint-free cloth towel and secured by Elastoplast. All wrapping materials and adhesive dressings were removed after 4 hours, and the application site was rinsed with 0.9% saline and towel dried to remove excess test material.

All animals surviving to study termination were euthanised, necropsies were not performed.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not relevant
Remarks on result:
other: No signs of dermal irritation or corrosivity were seen in any rabbit during the study
Irritant / corrosive response data:
No signs of dermal irritation or corrosivity were seen in any rabbit during the study.
Other effects:
None documented

Any other information on results incl. tables

No signs of dermal irritation or corrosivity were seen in any rabbit during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No signs of dermal irritation or corrosivity were observed in any rabbit during the study.
Executive summary:

Isophthalic acid was applied undiluted for 4 hours to the shaved back of three New Zealand White rabbits at a concentration of 0.5g. All test sites were examined for signs of dermal irritation and corrosivity 30 - 60 minutes, 24, 48 and 72 hours following removal of the wrappings. The irritation score was 0.0/8.0 at all time points following unwrapping. The Primary Dermal Irritation Score was 0.0. No signs of dermal irritation or corrosivity were observed in any rabbit.