Registration Dossier

Administrative data

Description of key information

In Compliance with the OECD Guidelines 404 (Acute Dermal Irritation / Corrosion) test:

The application of 0.5 ml of the substance UG batch 97302300 for 4 hours under a semi-occlusive patch to the skin of 3 rabbits, produced, one hour after patch removal, a slight erythema in 1 animal and a slight oedema in another one. The third rabbit did flot exhibit any cutaneous reaction. During the 72 following hours, irritation reactions had totally disappeared.

According to the 67/548/EEC order classification, the substance UG batch 97302300 is unclassified among the substances irritating to skin.




 In Compliance with the OECD Guidelines 405 (Acute Eye Irritation / Corrosion) test:

The instillation of the substance UG - batch 97302300 at the dose of 0.1 ml into the eye of three rabbits, produced one hour after instillation, in ail the animals, the outbreak of diffuse purple enanthemae with important lacrimations and chemosis. A congestion ofthe iris was also noted in the 3 animals and a slight and partial opacification of the cornea was found in two of them.24 hours afier instillation, these reactions were maintained and severe cornea lesions werc evidenced in the three rabbits. A pannus noted on the cornea of two rabbits on D9 was maintained till D19 for one of them and D21 for the second one. The reversibility of the ocular reactions was flot complete at the end ofthe 21-day-observation period in two of the animals.

According to the 67/548/EEC order classification the substance UG batch 97302300 is classified among the substances irritating to eyes (with important ocular lesions).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 17 November 1997 to 07 December 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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:
- Species, strain, supplier : New-zealand albino rabbit, Charles RIVER (76110 Saint Aubin
Les Elbeuf France).
Reason for species selection : the New-zealand albino rabbit is the animal traditionally used for the evaluation of irritant potential of products and is the animal chosen by the regulatory authorities.
- Number and sex: 3 females
If strong effects are foreseeable, the test is performed in one animal. From the results obtained, the test may be flot realized in the two others.
- Average weight: 2.4 kg
- Identification: auricular ring
- Acclimatization : at ieast 5 days
- Housing, diet : environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline (individuai housing on floor grid). Complete peileted rabbit maintenance diet ERGILAP Anco, COFNA (37018 - TOURS, FRANCE).
- Preparation: approximately 24 hours before the test, fur is removed by clipping from the dorsal area of the trunk of the animais. Care is taken to avoid abrading the skin. Only animais with heaithy intact skin are used.
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
The test material is applied under a semi-occlusive patch to the skin of the 3 rabbits at the dose of 0.5 g!rabbit according to the foilowing procedure
• 0.5 mi ofthe test material (previously pounded in a mostar) are appiied to the ciipped skin, then covered with a gauze (2.5 x 2.5 cm) heid in place by means of a 5 x 5 cm wide “Micropore” fastening tape. Then the animais trunk is wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width, place in such a way so as flot to hinder respiratory movements.
• the rabbits are returned to their cages for 4 hours at the end of which the dressing and the gauze patch are removed. Then, residuai test substance is removed, using absorbent paper moistened with distiiled water.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Irritant / corrosive response data:
Under the experimental conditions adopted, the application of the substance UG batch 97302300 for 4 hours to the skin of the rabbit, produced, 1 hour after patch removal, the formation of a slight erythema in 1 rabbit and a slight oedema in another one. No cutaneous reactions were seen on the last animal. During the first 72 hours, erythematous and oedematous reactions had disappeared in both of them.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the 67/548/EEC order classification, the substance UG batch 97302300 is unclassified among the substances irritating to skin.
Executive summary:

The application of 0.5 ml of the substance UG batch 97302300 for 4 hours under a semi-occlusive patch to the skin of 3 rabbits, produced, one hour after patch removal, a slight erythema in 1 animal and a slight oedema in another one. The third rabbit did flot exhibit any cutaneous reaction. During the 72 following hours, irritation reactions had totally disappeared.

According to the 671548/EEC order classification, the substance UG batch 97302300 is unclassified among the substances irritating to skin.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 November 1997 to 07 December 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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:
- Species, strain, supplier : New-zealand albino rabbit, Charles RIVER (76110 Saint Aubin Les Elbeuf France).
Reason for species selection the New-zealand albino rabbit is the animal traditionally used for the evaluation of irritant potential of products and is the animal chosen by the regulatory authorities.
- Number and sex 3 females
If strong eyes effects are foreseeable, the test is performed in one animal. From the results obtained, the test may be flot realized in the two others.
- Average weight: 2.4 kg
- Identification: auricular ring
- Acclimatization : at least 5 days
- Housing, diet : environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline (individual housing on floor grid). Complete pelleted rabbit maintenance diet ERG]LAP Anco, COFNA (37018 - TOURS, FRANCE).
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye as control
Amount / concentration applied:
100 mg
Observation period (in vivo):
after 1h, 24h, 48h and 72 hour,up to 21 days
Number of animals or in vitro replicates:
3
Details on study design:
After checking that the rabbit has healthy, defect-free eyes, the test material is placed at a dose of 0.1 ml or 0.1 g if test substance is pasty or solid in the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball.
The lids are then gently held together for about one second in order to prevent loss of the material.
The other eye, which remains untreated, serves as a control.
Afler a one hour period of contention, the animal is returned to its individual cage.
In this study, the test substance is used as such at the dose of 0.1 mI/eye (after pounding it in a mortar).
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 21 days
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the 67/548/EEC order classification, the substance UG batch 97302300 should be considered as irritant to eyes (with formation of important ocular iesions).
Executive summary:

The instillation of the substance UG - batch 97302300 at the dose of 0.1 ml into the eye of three rabbits, produced one hour after instillation, in ail the animals, the outbreak of diffuse purple enanthemae with important lacrimations and chemosis. A congestion ofthe iris was also noted in the 3 animals and a slight and partial opacification of the cornea was found in two of them.


24 hours afier instillation, these reactions were maintained and severe cornea lesions werc evidenced in the three rabbits. A pannus noted on the cornea of two rabbits on D9 was maintained till D19 for one of them and D21 for the second one. The reversibility of the ocular reactions was flot complete at the end ofthe 21-day-observation period in two of the animals.


According to the 67/548/EEC order classification the substance UG batch 97302300 is classified among the substances irritating to eyes (with important ocular lesions).

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

Unclassified for Skin Irritation:

Based on results from the experimental study under a semi-occlusive patch to the skin of the 3 rabbits at the dose of 0.5 g rabbit in compliance with the OECD Guidelines 404 Acute dermal Irritation/Corrosion:

According to the 67/548/EEC order classification, the substance UG batch 97302300 is unclassified among the substances irritating to skin.



Classified as Eye Irritating (with important ocular lessions):

Based on the results from the experimental study done under the OECD Guidline on the eye irritation of the test item, the eversibility of the ocular reactions was flot complete at the end of the 21-day-observation period in only two of the animals.

According to the 67/548/EEC order classification the substance UG batch 97302300 is classified among the substances irritating to eyes (with important ocular lesions).