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Description of key information

Both for skin and eye, in vivo irritation studies are available, which have been performed according to OECD test guidelines. In these studies, the substance did not show significant irritation in either eye or skin.

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 January - 27 January, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed equivalent or similar to OECD 404 guideline. Limited information about substance identity and no GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
first version 1981.
Deviations:
yes
Remarks:
Occlusive instead of semi-occlusive, but not considered to have affected the reliability.
GLP compliance:
no
Remarks:
performed before GLP was in place in the EU.
Species:
rabbit
Strain:
other: white Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14, Germany
- Age at study initiation: 5 months
- Weight at study initiation: 2.2 - 2.4 kg (males and females)
- Housing: Single in stainless steel cages modell Asta
- Diet (e.g. ad libitum): standard rabbit diet (Altromin R)
- Water: Free access to tap water
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 50 - 60
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with 0.15 mL Aqua dest
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
STUDY DESIGN
The test substance was applied under a 6.25 cm2 patch to intact skin on each animal. The patches were covered by an overlapping patch of adhesive plastic. The whole area was then bound by occlusive tape (Acrylastic, Beiersdorf and Co.) wrapped round the entire trunk of the animal.

TEST SITE
The rabbits were prepared by shaving the skin of the back free of hair. The left and right site of the back were split up in four patch test areas and two areas were abraded.

SCORING SYSTEM:
The irritation scores were recorded.The irritation was assessed according to OECD 404.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test substance caused no erythema and no edema at any time point on the intact skin test sites.
Other effects:
No signs of systemic intoxication were observed during the study period.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a skin irritation study with rabbits, performed equivalent or similar to OECD 404 guideline, no irritation was observed.
Executive summary:

In a skin irritation study performed according to OECD test guideline 404, the substance (0.5 g) was applied onto the shaved skin of three rabbits using occlusive dressings for 4 hours. Under the conditions of this study, no irritation was observed for 72 hours. The test substance caused no erythema and no edema on the intact skin test sites. No signs of systemic intoxication were observed during the study period.

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:
18 January - 08 February, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed equivalent or similar to OECD 405 guideline. Limited information about substance identity and no GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
GLP compliance:
no
Remarks:
performed before GLP was in place in the EU.
Species:
rabbit
Strain:
other: white Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14, Germany
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.0-2.2 kg (males and females)
- Housing: One animal per cage in stainless steel cages Modell Asta
- Diet (e.g. ad libitum): standard diet (Altromin®)
- Water: free access to water
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL - Amount(s) applied: 100 mg
Duration of treatment / exposure:
Single instillation on Day 1.
Observation period (in vivo):
1, 24, 48 and 72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
TREATMENT
The test substance was introduced into the conjunctival sack of one eye. The lids were gently held together for one second.

REMOVAL OF TEST SUBSTANCE
-Washing (if done): No

OBSERVATIONS
- Mortality/Viability: No data available
- Toxicity: No data available
- Body Weight: No data available
- Necropsy: No data available
- Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
The irritation scores were recorded.The irritation was assessed according to OECD 405.

Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hrs
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
animal #2 and #3
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritant / corrosive response data:
In animal #1 a conjuctivae score (redness) grade 1 was observed. This observation was fully reversible within 72 hours.
Other effects:
No signs of systemic intoxication were observed during the study period.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study with rabbits, performed equivalent or similar to OECD 405 guideline, no significant irritation was observed.
Executive summary:

In an eye irritation study performed according to OECD test guideline 405, one eye of each of three rabbits was treated with 0.1 g sodium ferrocyanide. In one animal a conjuctivae score (redness) grade 1 was observed. This observation was fully reversible within 72 hours. No further irritation was observed in any of the animals treated. No signs of systemic intoxication were observed during the study period.

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

Additional information

In a skin irritation study performed according to OECD test guideline 404, the (moistened) substance (0.5 g) was applied onto the shaved skin of three rabbits using occlusive dressings for 4 hours. Under the conditions of this study, no irritation was observed for 72 hours. The test substance caused no erythema and no edema on the intact skin test sites. No signs of systemic intoxication were observed during the study period.

In an eye irritation study performed according to OECD test guideline 405, one eye of each of three rabbits was treated with 0.1 g sodium ferrocyanide. In one animal a conjuctivae score (redness) grade 1 was observed. This observation was fully reversible within 72 hours. No further irritation was observed in any of the animals treated. No signs of systemic intoxication were observed during the study period.


Justification for selection of skin irritation / corrosion endpoint:
One study available with Klimisch reliability 2. The study has been performed equivalent or similar to OECD 404 guideline. Study has however limited information about substance identity and was not performed according to GLP guidelines.

Justification for selection of eye irritation endpoint:
One study available with Klimisch reliability 2. The study has been performed equivalent or similar to OECD 405 guideline. Study has however limited information about substance identity and was not performed according to GLP guidelines.

Justification for classification or non-classification

According to the available data, sodium ferrocyanide does not have to be classified for skin and eye irritation according to CLP Regulation (EC) No. 1272/2008.