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Administrative data

Description of key information

Atlen SK is not a skin/eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion
Data waiving:
other justification
Justification for data waiving:
other:
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
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
other: New Zeland
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Reproductive Farm of Rabbits, Balice, Poland
- Age at study initiation: 5.5 months (rabbit No. 1) and 6 months (rabbits No. 2 and No. 3)
- Weight at study initiation: rabbit No. 1 - 3.3 kg, rabbit No. 2 - 3.2 kg, rabbit No. 3 - 3.0 kg
- Housing: animals were kept individually in metal cages of dimensions (length x width x height) 60 x 35 x 40 cm. The cages were equipped with lables containing information on study code, the date of the beginning and of the end of the experiment, sex and animal's number.
- Diet (e.g. ad libitum): ad libitum. The animals were fed standard granulate feed "LSK" produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz, Poland
- Water (e.g. ad libitum): ad libitum. Tap water.
- Acclimation period: 5 days quarantine

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 43 - 55 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark

IN-LIFE DATES: From: To:
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml was administered in uniluted form
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing was not performed

SCORING SYSTEM: according to the OECD TGD No. 405

TOOL USED TO ASSESS SCORE: the character of changes made application of any tools unnecessary - the changes were visible with a naked eye
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: average of 24, 48 and 72 hrs
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: average of 24, 48 and 72 hrs
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: average of 24, 48 and 72 hrs
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: average of 24, 48 and 72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: average of 24, 48 and 72 hrs
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: average of 24, 48 and 72 hrs
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: average of 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable, as no effects were seen
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: average of 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable, as no effects were seen
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: average of 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable, as no effects were seen
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: average of 24, 48 and 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: not applicable, as no effects were seen
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: average of 24, 48 and 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: not applicable, as no effects were seen
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: average of 24, 48 and 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: not applicable, as no effects were seen
Irritant / corrosive response data:
After administration of test item pathological changes were stated in conjunctiva of eyes of rabbits. No changes in cornea and iris were observed.
During reading after 1 hour since administration of test item erythema in form of diffuse crimson redness (individual vessels hardly visible) was stated in conjunctiva of rabbit No 1 and No 3, whereas erythema in form of diffuse beefy redness was observed in rabbit No 2. Furthermore, congestion of nictating membrane and circumcorneal injection were stated in three rabbits. Distinct swelling of conjunctiva with partial eversion of eyelids was observed in rabbit No 1 and rabbit No 3. Swelling of nictating membrane was stated in three rabbits. Excretion on lids, lids’ hair and considerable part of eye region was stated in rabbit No 1, excretion on lids and lids’ hair in rabbit No 2 and No 3.
During reading after 24 hours since administration of test item erythema in form of diffuse crimson redness, congestion of nictating membrane, circumcorneal injection as well as swelling of nictating membrane and excretion on lids and lids’ hair were stated in conjuctivas of three rabbits. Slight swelling of conjunctiva was observed in rabbit No 1 only.
During reading after 48 hours since administration of test item erythema in form of diffuse crimson redness was observed in conjunctiva of rabbit No 1, injection of some blood vessels was stated in rabbit No 2 and No 3. Congestion of nictating membrane was stated in three rabbits. Swelling of nictating membrane and slight volumes of excretion were observed in rabbit No 1 and No 2.
During reading after 72 hours since administration of test item congestion of some blood vessels and congestion of nictating membrane were stated in three rabbits. Swelling of nictating membrane and slight volumes of excretion were observed only in rabbit No 1.
During reading after 7 days since administration of test item congestion of some blood vessels was stated in rabbit No 1. No pathological changes were stated in eyes of the remaining two rabbits.
During reading after 14 days since administration of test item no pathological changes were observed in conjunctiva of rabbits.
See Table 1 in section any other information on results incl. tables for the recorded scores.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Atlen SK was tested in vivo with respect to skin/eye irritability.

In acute dermal toxicity study on rats Atlen SK did not induce any signs of local irritation at the limit concentration of 2000 mg/kg bw.

In eye irritation study on rabbit Atlen SK did not induce eye irritation.


Justification for selection of skin irritation / corrosion endpoint:
One study available.

Justification for selection of eye irritation endpoint:
One study available.

Justification for classification or non-classification

Data available for Atlen SK is conclusive but not sufficient for the classification of Atlen SK with regard to skin/eye irritation.