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Diss Factsheets

Administrative data

Description of key information

Acute dermal irritation test with male rabbits (EC B4, OECD 404, OPPTS 870:2500): not irritating

Acute eye irritation test with male rabbits (EC B.5, OECD 405, OPPTS 870.2400): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
Existing In-Vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 July 2004 to 13 September 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP in accordance with an internationally recognised test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Deionised water
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, and 72 hours after test substance removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:6 cm²
- Type of wrap if used: 1-inch, 2-ply gauze square which was held in place with non-irritating tape and covered with porous tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
No dermal irritation was observed in the three rabbits.
Other effects:
The rabbits exhibited no clinical signs during the study.
No biologically important bodyweight losses were observed.
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
Existing In-vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 July 2004 to 3 January 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP in accordance with an internationally recognised test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Annex V
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit was not treated with the test substance and served as a control.
Amount / concentration applied:
Approximately 100 mg (a weight equal to a 0.1 mL volume)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: eyes were examined using illumination and magnification
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
0.33
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Corneal opacity (score of 1), iritis (score of 1), and conjunctival redness (score of 1) were observed in the treated eyes of two rabbits. Additionally, discharge (score of 2) was observed in the treated eye of one of these rabbits. Conjunctival chemosis (score of 1) and discharge (score of 3) were observed in the treated eye of the remaining rabbit. The treated eyes of the rabbits were normal by 24 or 48 hours after instillation of the test substance.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

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

Additional information

Skin irritation

In a study conducted in accordance with OECD guidelines and under Good Laboratory Practice, Terracess TF-L was applied as a single 0.5 g dermal dose to the shaved intact skin of 3 male New Zealand White rabbits. The test substance, moistened with approximately 0.3 mL of deionized water, was applied to a 6 cm² area of skin and the application area covered with a semi-occlusive dressing. The rabbits were exposed to the test substance for 4 hours after which the test substance was removed. Test sites were evaluated for signs of dermal irritation 1, 24, 48, and 72 hours after test substance removal.

 

No dermal irritation or clinical signs were observed in the three rabbits and no biologically important body weight loss occurred.

Eye irritation

In a study conducted in accordance with OECD guidelines and under Good Laboratory Practice, Terracess TF-L was evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. Approximately 100 mg of test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored approximately 1, 24, 48, and 72 hours following administration of the test substance. Corneal opacity (score of 1), iritis (score of 1), and conjunctival redness (score of 1) were observed in the treated eyes of two rabbits. Additionally, discharge (score of 2) was observed in the treated eye of one of these rabbits. Conjunctival chemosis (score of 1) and discharge (score of 3) were observed in the treated eye of the remaining rabbit. Fluorescein stain examinations were negative for corneal injury in the treated eyes of all rabbits. The treated eyes of the rabbits were normal by 24 or 48 hours after instillation of the test substance. No clinical signs were observed, and no body weight loss occurred.

Respiratory irritation

In the acute inhalation toxicity study according to OECD 403, no signs of irritation were observed in the exposed animals. Terracess TF is expected to cause no respiratory irritation.

Justification for selection of skin irritation / corrosion endpoint:

One available and valid study

Justification for selection of eye irritation endpoint:

One available and valid study

Justification for classification or non-classification

Dermal irritation - no dermal irritation observed .Scores for individual rabbits were zero at all timepoints for erythema and edema.

Eye - no irreversible damage occurred and the mean scores (over 24, 48 and 72 hours) for each animal were 0.33 or less.

Terracess TF does not meet the classification criteria for skin or eye irritation.