Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritant

Eye irritation: eye damage

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-09-12 to 1989-10-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
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: Hagemann Gmbh&Co- Weight : 2.3 kg (medium)- Housing: individually cages- Diet: "Mummel Z" (Ssniff Spezialdiäten GmbH, Soest)- Water: tap water ad libitum consultion- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 216-18- Humidity (%): ca. 40 - Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL- Amount applied: 0.5 g moistened with water
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 males
Details on study design:
TEST SITE- Area of exposure: 8 cm²- 2.5 x 2.5 cm large pieces of double-layer surgical gauze were filled with 500 mg of substance with water and fixed with a patch on the right side of the animals.REMOVAL OF TEST SUBSTANCE- Washing (if done): yes, with water- Time after start of exposure: 4 hoursSCORING SYSTEM: according to Draize
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: not determined due to the coloring effect of the substance
Irritation parameter:
edema score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
no irritating effects
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal irritation/corrosion study according to OECD 404 the test substance was found to be non-irritating to the skin.
Executive summary:

In a primary dermal irritation study (OECD guideline 404), three male New Zealand white rabbits were dermally exposed to 0.5 g of the test item for 4 hours to a body surface area of 8 cm² under semi-occlusive conditions. Animals then were observed for 1, 24, 48, 72 hours and 8 days and irritation was scored by the method of Draize. The test substance did not cause any skin effects and is considered under the conditions of this study as not irritating to the skin.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-09-12 to 1989-10-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute 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: Hagemann Gmbh&Co- Weight : 2.3 kg (medium)- Housing: individually cages- Diet: "Mummel Z" (Ssniff Spezialdiäten GmbH, Soest)- Water: tap water ad libitum consultion- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 216-18- Humidity (%): ca. 40 - Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100 µL
Duration of treatment / exposure:
1 second eye lids gently close
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE: the treated eyes were not rinsedSCORING SYSTEM: according to Draize and McDonals and ShadduckTOOL USED TO ASSESS SCORE: fluorescein in ophtalmological solution (1 drop)
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: all animals showed effetcs
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: all animals showed effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: all animals showe effects
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: all animals showed a mean chemosis score of 4
Irritant / corrosive response data:
All animals showed strong effect on cornea, iris and conjunctivae.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In an acute eye irritation/corrosion study according to OECD 405, the test substance causes severe eye-irritating effects.
Executive summary:

In a primary eye irritation study, 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of three male New Zealand White rabbits. The animals were observed for a period of 8 days.
In this study, the test item is corrosive to the eye based on effects on conjunctivae, cornea and iris.

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 results of the test performed on BY29 and similar substances, the following classification is required:
Eye damage 1, H318.