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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an O.E.C.D. Testing Guideline under the GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid at room temperature.
Details on test material:
As per IUCLID5 Sections 1.1, 1.2. and 1.4.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
New Zealand White rabbits of the Crl:NZW/Kbl.BR strain were obtained from Charles River UK Ltd, Margate. The animals were examined and weighed on the day of arrival. The rabbits were in a body weight range of 2.45 to 2.69 kg on the day prior to dosing. The rabbits were approximately eleven to fourteen weeks old on Day 1 of the study. Rabbits were housed in floor-pens, each accommodating one animal throughout the acclimatisation and experimental phases of the study. Each pen had a minimum floor area of 0.6 sq m. Wood chips were provided as floor litter. Each batch of wood chips was analysed for specific contaminants.

SQC TRB Rabbit Diet 9603 (pelleted) from Harlan Teklad, Bicester was freely available to the animals at all times. Each batch of diet had been analysed for specific constituents. Mains water was provided, ad libitum, via water bottles attached to the pen walls, The water had been periodically analysed for specific contaminants. No contaminants were present in diet, bedding or water at levels which might interfere with achieving the objective of the study.

The holding room was designed to permit at least 10 air changes per hour and to maintain environmental conditions of 16 to 22°C. Humidity was not actively controlled but was expected to remain within the range 40-80% Relative Humidity. Recordings of maximum and minimum temperature and humidity were made twice daily and any minor deviations from the expected ranges were noted in the study data. The room was illuminated by fluorescent strip-lights for twelve hours daily.

The condition of the animals was assessed daily throughout an acclimatisation period of at least one week. A clinical inspection was performed prior to study commencement to ensure the animals were suitable for the test procedures. Healthy animals, weighing not more than 4.0 kg, were arbitrarilyallocated to the study on the day prior to commencement of treatment.



Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL of undiluted test substance.
Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3
Details on study design:
The animals were prepared for treatment with test substance with electric clippers that were used to remove all hair from an area of the dorsum measuring not less than l0x8cm. The dermal test site, a 30 x 20 mm area on the clipped dorsum of the three New Zealand White rabbits was subject to application of 0.5 mL of undiluted 2,3-epoxypropyl neodecanoate. The applied dose was spread uniformly over the designated area and then covered by a dense gauze patch (30 x 20 mm). This in turn was covered by a larger gauze patch (40 x 40 mm) and an open weave, elasticated adhesive bandage “Steroban” from Steroplast Ltd, Bredbury which was wrapped firmly around the torso to secure the applied dose in the correct position. The dressing was considered to be semi-occlusive. The dressing was removed after four hours. The test site was lightly brushed clean of any solid residues and swabbed with moist cotton wool. The site location was marked on the dorsum with indelible ink after completion of the cleansing process. A detailed account of any clinical signs of ill health or systemic toxicity was maintained. The conditions of the dermal test sites were recorded immediately after removal of the patches and dressings. The condition of all dermal test sites was recorded one hour, 24, 48 and 72 hours after removal of the patch and dressing. Further observations were recorded on Day 8 and Day 15. Inflammatory skin reactions were graded from 0 - 4 for erythema, eschare and oedema.


Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0.7
Max. score:
0.7
Reversibility:
fully reversible within: 15 d
Irritant / corrosive response data:
The only evidence of skin irritation observed in the study was an erythema score of 1 for two animals at 72 hours and a score of 1 for one animal at the 24 hr observation time.

Any other information on results incl. tables

Tables showing the individual animal dermal reactions and Group mean dermal scores are attached below.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the dermal observations made during this study 2,3-epoxypropyl neodecanoate is not irritating to rabbit skin under the experimental conditions
Executive summary:

Under the conditions of an O.E.C.D. 404 Testing Guideline study undiluted 2,3 -epoxypropyl neodecanoate was not irritating to rabbit skin following four hr of exposure.