Registration Dossier

Administrative data

Description of key information

GLP guideline study according to OECD 404 and 405

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:
October 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchil Ltd. Huntingdon, UK and Interfauna Uk Ltd.
- Age at study initiation: adult
- Weight at study initiation:
- Housing: individual wire mesh, Type III-high
- Diet (e.g. ad libitum): ssniff K 4, ad libitum
- Water (e.g. ad libitum): water from automatic water dispenser, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (+/-2)°C
- Humidity (%):45 - 65%
- Air changes (per hr): 10-fold
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h Light
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): in water

VEHICLE
- Amount(s) applied (volume or weight with unit): 500 mg in Water on Hansamed 'Hypoallergen' (Baiersdorf No. 2342) on a 6 cm² skin surface
Duration of treatment / exposure:
4 h
Observation period:
24, 48 and 72 h after removal of the patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal region of the body
- % coverage: 6 cm²
- Type of wrap if used: test substance evenly distributed on sterile plaster. The plaster was fixed to the prepared skin area and then coverd with semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 h

SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: 1, 24, 48 and 72 hours and 7 and 14 days
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: 1, 24, 48 and 72 hours and 7 and 14 days
Score:
0
Max. score:
4
Irritant / corrosive response data:
No abnormalities detected in any of the tested animals at different time points up to 72 h
Other effects:
None

No signs of irritations were observed during the whole observation period

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance was considered to be non-irritating to rabbit skin
Executive summary:

A study was conducted to assess the skin irritation potential of test substance to the rabbit skin according to EU Method B.4. and OECD Guideline 404 in compliance with GLP.

Three animals were treated with 500 mg of the test substance pasted with water using semi-occlusive patches for 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with water. The skin was evaluated for erythema, eschar formation and edema numerically according to the score of Draize system for up to 72 h after patch removal.

No signs of irritation were observed during the whole observation period.

Under the test conditions, the test substance was considered to be non-irritating to rabbit 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:
October 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd. Huntington, UK and Interfauna UK Ltd.
- Age at study initiation: adult
- Housing: individual, wire mesh Type III-high
- Diet (e.g. ad libitum): ssniff K 4, ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Humidity (%):45-65 %
- Air changes (per hr): 10-fold
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µg/l (= 70 mg)
- Concentration (if solution): mixed with water to obtain paste

Duration of treatment / exposure:
single treatment / 4 h
Observation period (in vivo):
24, 48, and 72 h after removal of patches
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 24 h after administration the treated eyes were washed out thoroughly with isotonic saline (NaCl) solution
- Time after start of exposure: 24 h

SCORING SYSTEM: Lesions in cornea, iris or conjunctivae were graded numerically 'Scale for scoring ocular reactions'

TOOL USED TO ASSESS SCORE: 1%-fluorescein solution, UV-light
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Other effects:
None
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance was considered to be non-irritating to the rabbit eye
Executive summary:

In a primary eye irritation study, 70 mg of Reactive Blue FC 15353 was instilled into the conjunctival sac of the left eye of 3 New Zealand albino rabbits for 24 hours. Treated eyes were washed with isotonic saline at approx. 37 degrees C 24 hours after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place. Animals were then observed for 3 days. Irritation was scored by the Draize method.

In this study, the test item is not considered an eye irritant.

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

Additional information

A study was conducted to assess the skin and eye irritation potential of the test substance according to OECD Guideline 404 and 405 in compliance with GLP. Under the test conditions, the test substance was considered to be non-irritating to rabbit skin or eye.


Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study

Justification for selection of eye irritation endpoint:
GLP guideline study

Justification for classification or non-classification

No effects reported in appropriate GLP guideline studies.