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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:
1988-05-24 to 1988-05-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test substance not described in sufficient details.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Witamol 110
- Substance type: product
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: at room temperature in a glass screw-top bottle
- Other: none

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: approx. 12-16 weeks
- Weight at study initiation: 2.25 - 2.51 kg
- Housing: single housing in suspended metal cages
- Diet (e.g. ad libitum): free access to Rabbit Diet, supplied by Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (e.g. ad libitum): free access to mains drinking water throughout the study
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 19
- Humidity (%): 68 - 75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
5 females, 1 male
Details on study design:
TEST SITE
- Area of exposure: clipped skin on the dorsal/flank area, intact epidemis
- % coverage: not mentioned
- Type of wrap if used: On the application area a gauze patch (2.5 cm x 2.5 cm) was placed. The patch was secured in position by a strip of surgical adhesive tape (BLENDERM: approx. size 2.5 cm x 4.0 cm). The trunk of the animals was wrapped in an elasticated corset (TUGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Draize J. H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, ¿ The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics¿

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.72
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.61
- Edema: 0.11
Other effects:
none

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

0/0/1/0/0/1

 0/0/0/0/0/0

24 h

 0/0/2/0/1/2

 0/0/1/0/0/1

48 h

 1/1/1/1/1/1

 0/0/0/0/0/0

72 h

 0/0/0/0/0/0

 0/0/0/0/0/0

Average 24h, 48h, 72h

0.61 

 0.11

Reversibility*)

 c.

 c.

Average time (unit) for reversion

 72 hours

 48 hours

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Very slight erythema was noted at two treated skin sites on hour after removal of the patches. Very slight or well-defined erythema, with or without very slight oedema, was noted at three treated skin sites at the 24 h observation. Very slight erythema persisted in all treated skin sites at the 48 h observation. All treated skin sites appeared normal at the 72 h observation.

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters produced a primary dermal irritation index (PDII) of 0.72 was classified as slightly irritant to rabbit skin.
Executive summary:

The study was performed to assess the irritancy potential of 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters to the skin of the New Zealand White rabbit. The study was designed to comply with the requirements of the USA Environmental Protection Agency (EPA).

A single 4 -hour, semi-occluded application of the test material to the skin of six rabbits produced very slight to well-defined erythema with or without very slight oedema. All treated sites appeared normal 72 hours after treatment.

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters produced a primary dermal irritation index (PDII) of 0.72 and should not be classified according to EU Nr. 1272/2008.