Registration Dossier

Administrative data

Description of key information

No irritating or corrosive effects

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:
13 July to 02. September 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP
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, occlusive scarified 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: 13 to 16 July 1976
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:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per shaved and abraded skin each
- Concentration (if solution): NA

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:
edema score
Remarks:
shaved skin
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 h to 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 h to 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
shaved skin
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 h to 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 h to 72 h
Score:
0
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 h + 72 h
Score:
0
Max. score:
8
Irritant / corrosive response data:
no signs of irritation were noted
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
EU Classification: not irritating
Executive summary:

The irritation potential of Reactive Red 180 was tested in the flank skin of 6 rabbits with shaved and abraded skin. No signs of skin irritation were noted either in shaved or in abraded skin with 500 mg undiluted test substance.

Consequently, the test substance is not irritating to skin.

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:
13 July to 02. September 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP
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)
Weight at study initiation: 1.5 to 2 kg
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): 100 mg
- Concentration (if solution): NA
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 surved 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)
Remarks:
Maximum Average Score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 7 hours
Score:
12
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Maximum Average Score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24 hours
Score:
5
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Maximum Average Score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 48 h
Score:
1
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Maximum Average Score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
110
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

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

Additional information

Skin irritation / Corrosion

The test item was tested for skin irritation properties. The evaluation of the erythema and edema scores at the 24, 48, and 72 hour time points showed that the test item is not irritating to skin according to CLP/FDA evaluation schemes.

Eye irritation

The effects on rabbit eyes observed up to 72 hours (chemosis and/or reddening) do not result in any classification. The test item, applied to rabbit eye mucosa, caused conjunctival irritant effects at seven hours, which were reduced at 24 hours after application. Slight corneal opacity were observed at 7 and 24 hours in one out of six animals. All conjunctival irritation effects were completely reversed at the 72 hours observation period. Some slight discolouration of the conjuctivae remained at the observation period of 72 hours, but this is not considered as a classifiable effect under the CLP/FDA Regulation.

Respiratory irritation

Respiratory irritation was not assessed; however no effects on the animals were noted in any associated studies.

Justification for classification or non-classification

The above studies have all been ranked reliability 1 or 2 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted in compliance with agreed protocols.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008).