Registration Dossier

Administrative data

Description of key information

Slight reversible effects on rabbit eyes and skin were observed in reliable animal studies.

The effects on skin do not warrant classification and labelling in the EU. Applying UN GHS criteria, criteria for category 3 (skin) are fulfilled.

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:
14.1.-24.1.1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP (performed 1988), OECD conform, 3 animals used, observation period 7 days even if effects still visible, no autopsy
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Storage condition of test material: room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kgs
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum.
- Water: ad libitum
- Acclimation period: 4 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: back
- coverage: at least 6 sq. cm
- Type of wrap if used: non-irritating adhesive tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1,24,48,72 h and 7 d
Score:
1 - 2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h and 7 d
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h and 7 d
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h and 7 d
Score:
1 - 2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h and 7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h and 7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
EC 270-128-1 was found to be slightly irritant to skin, scores are below the threshold for classification and labelling as an irritant in the European Union which has not implemented GHS category 3 for skin irritation.
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:
14/01/1983-24/01/1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP (performed 1983), OECD conform, but experiment was stopped before all animals recovered
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period terminated at day 7 although one animal still showed symptoms
GLP compliance:
no
Specific details on test material used for the study:
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Storage condition of test material: room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 d
-Individual Identification: ear numbers

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
other: left eye untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
-CORNEA: non irritant = 0; slightly irritant = 1; irritant = 2; severely irritant = 3-4; corrosion = +
-IRIS: non irritant = 0; irritant = 1; severely irritant = 2; corrosion = +
-CONJUNCTIVEAE: non irritant= 0; slightly irritant = 1; irritant = 2; severely irritant = 3; corrosion = +
-CHEMOSIS: no swelling = 0; slight swellinig = 1; swelling = 2; severe swelling = 3-4

TOOL USED TO ASSESS SCORE: no data
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h and 7 d
Score:
0
Max. score:
4
Remarks on result:
other: animal 37/m scored 1 at 1h and reversed to 0 at 24 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h and 7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Remarks:
one animal with score of 1 on day 7
Remarks on result:
other: Two animals fully reversed after 7 days.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h

cornea findings

animal no. 1 2 3
1h 0 0 0
24h 0 0 0
48h 0 0 0
72h 0 0 0

iris findings

animal no. 1 2 3
1h 0 0 0
24h 0 0 0
48h 0 0 0
72h 0 0 0

conjunctivae findings

animal no. 1 2 3
1h 1 2 2
24h 2 2 1
48h 2 1 1
72h 1 1 1
7 days 0 0 1

chemosis

animal no. 1 2 3
1h 1 0 1
24h 1 0 1
48h 1 0 1
72h 0 0 1
7 days 0 0 0
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The findings observed in the two studies do not meet the criteria for classification and labelling as an irritant according to Directive (EC) No 1272/2008.