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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05. Feb to 08 Feb 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: Federal Register 38, No 187
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
FDA Federal Register 38, No 187, Patch-Test, occusive scarifized and intact skin
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
SPF Himalayan Albino Rabbits: Hoe:HIMK(SPFWiga)
Source: Hoechst AG
Food: ERKA 8300
Supplier: Futtermittelwerke Robert Koch oHG Hamm
Water: Tap water
Food and water ad libitum
Single housing
Weight: 1.5 to 2 kg

In-life date: 05. Feb to 08 Feb 1979
Type of coverage:
occlusive
Preparation of test site:
other: abraded (3x3 cm) and shaved (3x3 cm) skin
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted, 0.5 mL on 2.5 cmx2.5 cm gauze pads
Duration of treatment / exposure:
24 hours
Observation period:
up to 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure shaved and scarified skin: 2.5x2.5 cm
- Area of exposure shaved skin: 2.5x2.5 cm
- Type of wrap if used: 6 to 8 cm wide PVC sheeting covered by elastic bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours


SCORING SYSTEM: FDA Federal Register 38, No 187

Erythema and eschar formation (EEF) :
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Edema formation (EF):
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exp.) 4

Mean value of 6 animals

Primary Irritation Index (PII) = EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved / 4

EVALUATION:

0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderately irritant
5.1 - 8.0 severely irritant
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24+72 h
Score:
0.8
Max. score:
8
Irritant / corrosive response data:
Two rabbits still showed a minimal erythema (score 1) at 72 hours.
Other effects:
In two rabbits dry skin was observed at 48 and/or 72 hours.
Interpretation of results:
not irritating
Remarks:
Migrated information based on evaluation of shaved skin Criteria used for interpretation of results: EU
Conclusions:
EU Classification: not irritating
FDA evaluation: slightly irritant
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 to 08 February 1979
Reliability:
2 (reliable with restrictions)
Qualifier:
according to
Guideline:
other: Federal Register 38, No. 187
Principles of method if other than guideline:
Federal Register 38, No. 187
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
SPF Himalayan Albino Rabbits: Hoe:HIMK(SPFWiga)
Food: ERKS 8300
Supplier: Futtermittelwerke Robert Koch oHG Hamm
Water: Tap water
Food and water ad libitum
Single housing
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test item was applied to the left eye of each rabbit. The contra-lateral eye served as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
28
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 7 hours
Score:
22
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
14
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
8
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 hours
Score:
2
Max. score:
110
Irritant / corrosive response data:
All animals: Nictitating membranes and conjunctive bluish stained up to 24 hours
Cornea minimally bluish stained in 5 rabbits on Day 1, still visible in 3 rabbits on Day 3. Due to the short postobservation period an the fact that the staining proved already to be reversible in 2 rabbits up to the end of the observation time. Full reversibility of the staining within a 14 day post-observation time is very liely.
Interpretation of results:
moderately irritating
Remarks:
Migrated information 1-hour reading Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Classification according to EU: no classification necessary
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification