Registration Dossier

Administrative data

Description of key information

A key study on skin irritation with the analogue substance octanoic acid, zinc salt, basic; demonstrate a lack of an irritation/corrosion potential. A key study on eye irritation indicates an irritating potential of the analogue substance octanoic acid, zinc salt, basic; effects are reversible. Furthermore, results of the histopathological examination of lung tissue following acute exposure to the structural analogue zinc dilaurate via inhalation (OECD 436 test, reported under acute inhalation toxicity) do not indicate an irritative potential to the respiratory tract.

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:
1992-10-20 to 1992-10-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981-05-12
GLP compliance:
yes
Species:
rabbit
Strain:
other: Kleinrussen, CHbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae GmbH, Biberach/D.
- Age at study initiation: approx. 9 months
- Weight at study initiation: approx. 2590 g
- Housing: individual accommodation
- Diet (ad libitum): Ssniff rabbit diet K4 (Ssniff GmbH, Soest/D, Batch: 770992/09)
- Water (ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: approx. 20-25 °C
- Relative humidity: approx. 45-70 %
- Air changes: at least eight per hour
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the undiluted test substance Stabiol VZN 1950 was applied at the dose level of 0.5 g per animal.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after exposure
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: the flank of each experimental animal was sheared approx. 24 hours prior to the application with an electric clipper. Animals with intact and healthy skin were used in the test.
The semi-occlusive exposure was performed by means of a 6 cm^2 adhesive air- and vapour permeable gauze-patch which was fixed by a hypoallergic adhesive gauze-bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposure was terminated after four hours by removing the patch and cleaning the relevant skin from the residual test substance.

SCORING SYSTEM: according to Draize scale
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No dermal effects were observed at all experimental animals up to 72 hours after exposure.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Stabiol VZN 1950 is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as skin irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin 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:
1992-11-09 to 1992-12-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1987-02-24
GLP compliance:
yes
Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
- Source: Thomae GmbH, D-Biberach
- Age at study initiation: approx. 10 and 22 month
- Weight at study initiation: approx. 2830 g
- Housing: individual accommodation
- identification of animal: ear tattoos and cage label
- Diet (ad libitum): Ssniff rabbit diet K4 (Ssniff GmbH, D-Soest; Charge: 770992/09)
- Water (ad libitum): tap water
- Acclimation period: 7/8 days

ENVIRONMENTAL CONDITIONS:
- Temperature: approx. 20 to 25 °C
- Relative humidity: approx. 45 to 70 %
- Air changes: at least 8 per hour
- Photoperiod (hrs dark / hrs light): artificial fluorescent light/ 12 hours dark







Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 0.1 mL of the undiluted test substance Stabiol VZN 1950 was placed in the conjunctival sac of the right eye. The left one remained untreated and served as the control.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours as well as 7, 14 and 21 days after exposure
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
According to the guidelines in a preliminary study one animal was treated because of the risk of severe eye injury.
Two additional experimental animals were treated in the same way.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were thoroughly rinsed with tepid tap water to complete the exposure.
- Time after start of exposure: 24 hours after instillation

SCORING SYSTEM: according to Draize scale

TOOL USED TO ASSESS SCORE:
Prior to the treatment, the eyes were examined by slit lamp microscope (Typ HSO-10; Fa. Carls Zeiss, Oberkochen) for their state of health and were judged to be healthy.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48,72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48,72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48,72 hours
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48,72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48,72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48,72 hours
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48,72 hours
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48,72 hours
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48,72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48,72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48,72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48,72 hours
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
Preliminary test: mild to strong erythema, weak to mild oedema and moderate to strong lacrimation were observed up to 72 hours after exposure. Weak corneal opacities were observed additionally up to 72 hours. All reactions disappeared completely within 14 to 72 hours. All reactions disappeared completely within 14 days.
Two further rabbits: the mild to strong erythema, mild to moderate oedema and mild to strong lacrimation at the other two experimental animals did not disappear within 72 hours. Weak to mild corneal opacities were observed additionally up to 72 hours. All reactions disappear completely within 22 days.
Interpretation of results:
other: Category 2 (irritating to eyes)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material is irritating to the eyes. The effects are reversible. According to 67/548/EC and subsequent regulations, the substance is classified as an eye irritant. According to the EC Regulation No. 1272/2008 and subsequent regulations, the substance is classified as Category 2 (H319: Causes serious eye irritation).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

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

Additional information

Justification for classification or non-classification

Zinc dioctanoate as slightly soluble zinc compound is not irritating or corrosive to the skin but irritating to the eyes. Therefore, the substance is classified as eye irritant category 2 (H319 Causes serious eye damage) according to EC Regulation No. 1272/2008.