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Diss Factsheets

Administrative data

Description of key information

The modified Primary Irritation Index is 3.01. This substance is non-corrosive and does not require a packing group assignment.
The tested substance is an ocular irritant, but not corrosive.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
Primary Dermal Irritation/Corrosion in Rabbits
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Initially, one healthy New Zealand White rabbit was placed in a restrainer and dosed with the test substance.
The day prior to the application of the test article, three (3) sites on the back of each animal, measuring approximately 3 x 3 cm each, were clipped free of hair. The sites remained intact. The test article (0.5 ml) was placed on the intact skin of the back (Site 1). The test article was kept in contact with the skin for three (3) minutes and scored for erythema and edema one hour following patch removal. Since the 3 minute exposure did not produce a definitive effect, two additional rabbits were added to the study. All three animals were dosed at site #2 for an exposure period of 1 hour and at site #3 for a four hour exposure. Each site was scored for erythema and edema one hour following patch removal, at 24, 48 and 72 hours and again on days 7 and 14. Animals were observed for systemic signs at each dermal scoring interval. A modified primary irritation index was calculated. Body weights were recorded pretest and at termination.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Initially, one rabbit was placed in a restraining stock and site #1 was dosed with 0.5 ml of the test article.
The test article was used as received, dosed by volume (0.5 ml/site) and placed on the clipped site under a 2.5 x 2.5 cm 4 ply surgical gauze patch. A plastic covering was held over the dose site in a semiocclusive manner for the three minute exposure period. Residual test article was removed from the test site by gentle washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions. The site was scored for skin reactions, including ulceration and necrosis, at 1 hour following patch removal.
Duration of treatment / exposure:
3 minutes
1 hour
4 hours
Observation period:
72 hours
Number of animals:
Three animals (two males and one female)
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
72 h
Score:
3.01

3 minute exposure:

There was no erythema or edema at 1 hour following patch removal.

1 hour exposure:

Erythema was absent at 1 hour following patch removal, absent to barely perceptible at 24 hours, absent to well defined at 48 hours, barely perceptible to well defined at 72 hours and absent on days 7 and 14. Edema was absent at 1 hour following patch removal, absent to well defined at 24 and 48 hours, barely perceptible to well defined at 72 hours and absent on days 7 and 14.

4 hour exposure:

Erythema was absent at 1 hour following patch removal, absent to well defined at 24 hours, barely perceptible to well defined at 48 hours, well defined to moderate at 72 hours and absent on days 7 and 14. Edema was absent at 1 hour following patch removal, absent to well defined at 24 and 48 hours, well defined at 72 hours and absent on days 7 and 14.

Systemic Observations:

There were no abnormal physical signs noted during the observation period.

Body Weights:

All body weight changes were normal.

Interpretation of results:
other: non-corrosive
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
The modified Primary Irritation Index is 3.01. This substance is non-corrosive and does not require a packing group assignment.
Executive summary:

The modified Primary Irritation Index is 3.01. This substance is non-corrosive and does not require a packing group assignment.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Only one study available. Study done according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions. Klimisch rating = 1.

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.2 and Chapter 3.3 it is classified to be non-irritating to skin, but eye irritating Category 2. (H319: Causes serious eye irritation.)