Registration Dossier

Administrative data

Description of key information

The test item showed no irritant effects on the skin of female rabbits in a study according to a OECD 404 (Hüls AG, 1996). The test item causes irreversible damage to eyes in a study according to OECD 405 in rabbits (Hüls AG, 1996).

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:
1996-03-11 to 1996-03-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: New Zealand white, HsdPoc:NZW
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Sex: female
- Weight at study initiation: 3.3; 3.6; 4.2 kg
- Housing: single
- Diet (e.g. ad libitum): Sniff K 4, complete feed for rabbits, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark rhythm

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Total volume applied: 0.5 ml undiluted test item
Duration of treatment / exposure:
4 hour(s)
Observation period:
30-60 minutes, 24, 48, and 72 hours after  patch removal
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Area of exposure: 6 cm2
- Total volume applied: 0.5 ml test item
- Occlusion: gauze dressing fixed with non-irritant plaster, Acrylastic  bandage
- Removal of test substance: washing with warm water
- Post exposure period: 3 days
EXAMINATIONS
- Examination time points: 30-60 minutes, 24, 48, and 72 hours after  patch removal
- Scoring system: OECD Guideline
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0
REVERSIBILITY: not applicable

no other results

Conclusions:
According to the study, the test item showed no irritant effect on the skin of female rabbits.
Executive summary:

The aim of this study was to examine the test item for acute skin irritation in rabbits (Patch-test) .

To test the acute skin irritant effect the test item was applied to the shaven dorsal skin of 3 female rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.

According to the study, the test item showed no irritant effect on the skin of female rabbits.
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:
1996-05-21 to 1996-06-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
other: Small white Russian, Mol:Russian / Chbb: HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Mol:Russian / Chbb: HM
- Source: Moellegaard Breeding & Research Cetre Ltd., 4623 Ll.Skensved  (Denmark)
- Sex: male
- Weight at study initiation: 3.2 - 3.3 kg
- Housing: single
- Diet (e.g. ad libitum): Sniff K 4, complete feed for rabbits, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark rhythm
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
undiluted test item
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
28 days
Number of animals or in vitro replicates:
3
Details on study design:
ADMINISTRATION/EXPOSURE 
- Vehicle: none
- rinsed after 24 hours
- Postexposure observation period: 28 days
EXAMINATIONS
- Ophtalmoscopic examination:  1 and 24, 48, 72 hours, 6, 8, 10, 13, 17, 21, 24 and 28 days  after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
2
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 28 days
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 1.33
- Iris: 0.44
- Conjunctivae (Redness): 1.00
- Conjunctivae (Chemosis): 2.00
- Overall irritation score: not reported
REVERSIBILITY: incomplete by day 28 (end of study), i.e. irreversible  damage
Other effects:
OTHER EFFECTS: Typical observations were: exsudation and circumcorneal  hyperemia (1-24 hours); bleeding in eyelids and nictitating membrnes  (24-72 hours); 
slight circumcorneal injection (day 6); recovery

AVERAGE SCORE
- Cornea: 1.33
- Iris: 0.44
- Conjunctivae (Redness): 1.00
- Conjunctivae (Chemosis): 2.00
- Overall irritation score: not reported
REVERSIBILITY: incomplete by day 28 (end of study), i.e. irreversible  damage
OTHER EFFECTS: Typical observations were: exsudation and circumcorneal  hyperemia (1-24 hours); bleeding in eyelids and nictitating membrnes  (24-72 hours); slight circumcorneal injection (day 6); recovery

Conclusions:
The test substance causes irreversible damage to eyes in a study according to OECD 405 in rabbits.
Executive summary:

This study was performed to examine eye irritating effects of test item according to OECD TG 405 in rabbits. 0.1 ml of undiluted test substance was applied in the conjunctival sac of one eye per animal of three male rabbits with rinsing after 24 hours.

Eye irritation index was assessed using Draize scale. The test was evaluated as follows (average of evaluation at 24, 48 and 72 hours respectively): cornea: 1.33, iris: 0.44, conjunctivae: redness: 1.00 and chemosis: 2.00 (mean scores on Draize scale). Typical observations were: exsudation and circumcorneal  hyperemia (1-24 hours); bleeding in eyelids and nictitating membranes  (24-72 hours);  slight circumcorneal injection (day 6); recovery. The reversibility were incomplete by day 28 (end of study), i.e. irreversible  damage.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available data the test item is not irritating to skin and therefore must not be classified according to criteria of EC Regulation 1272/2008.

Based on the available data the test substance causes irrversible damage to eyes and hence according to criteria of EC Regulation 1272/2008 the test substance is classified as eye damage Cat. 1; H318 "Causes serious eye damage".