Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The substance is not irritant for the skin and eye.

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:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed in accordance with validated guidelines and in GLP compliance.
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The age at treatment of the Rabbit was 10 weeks for male and 13-14 weeks for females. The Rabbit was placed under laboratory conditions after healt examinations. Only animals without any visual signs of illness were used for the study.
Air-conditioned with target ranges for room temperature 17-23 °C, relative humidity 30-70% and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled light cycle of
12 hours light and 12 hours dark. Music was played during the daytime light period.
Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4646 were provided for gnawing. Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum. Community tap water, ad libitum.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours alter the removal of the dressing, gauze patch and test item.
Number of animals:
3
Details on study design:
Four days before treatment, one flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was again clipped.
Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.5 mL of FEXO-03 was placed on a surgical gauze patch (ca. 4 cm x 4 cm). This gauze patch was applied to the intact skin of the clipped area. The
patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application sile so that any reactions
(erythema) were clearly visible at that time.
The observation has regarded the viability/mortality, the clinical signs and the body weights.
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 approximately 1, 24, 48 and 72 hours alter the removal of the dressing, gauze patch and test item.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. 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
Max. 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
Max. score:
0
Irritant / corrosive response data:
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) far each animal for erythema/eschar grades and for oedema grades, separately.
The mean erythema/eschar score and the mean oedema score of the three animals were 0.00.
Very slight erythema was observed in one animai at the 1-hour reading. No swelling (oedema) was noted in any animal at any time.
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
Coloration : no staining of the treated skin by the test item was observed.
Body weight : within the normal range of variability
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
FEXO-03 is considered to be "not irritating" to rabbit skin.
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:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed in accordance with validated guidelines and in GLP compliance.
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test animals were New Zealand White Rabbit, SPF. The age of the animals at tratment was 12- 13 weeks (male) and 18 - 19 weeks (females).
Air-conditioned with target ranges for room temperature 17-23 °C, relative humidity 30-70% and approximately 10-15 air changes per hour. Room temperature and humidity
were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not
to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
lndividually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4646 were provided for gnawing.
Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 52/03). Results of analysis for contaminants are archived at RCC Ltd.
Community tap water ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control.
Amount / concentration applied:
0.1 ml (per animal) of FEXO-03 was measured with a syringe and applied undiluted as it was delivered by the sponsor.
Duration of treatment / exposure:
On the day of treatment
Observation period (in vivo):
1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after instillation.
Number of animals or in vitro replicates:
3 (animals of both sexes were used)
Details on study design:
0.1 ml (per animal) of FEXO-03 was measured with a syringe and applied undiluted as it was delivered by the sponsor.
The pH of the test item was measured for a previous study (RCC Study number 851037, skin irritation with FEXO-03 in rabbits) and was found to be 6.
According to Directive 92/69 EEC, B.5. and OECD Guidelines 405, a test item needs not to be tested if the pH-value is less than 2 or greater than 11.5, owing to its predictable corrosive properties.
The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the
interpretation of the results were not used in the test.
On the day ol treatment, 0.1 ml of FEXO-03 was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss ol test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed alter instillation.
As the first animal screamed just after the application only this single animal (one male) was treated according to the study plan schedule. As neither a corrosive effect nor a severe irritant effect was observed alter the 1- and 24-hour examinations, the test was completed using the two remaining animals (two females).

OBSERVATIONS
Viability/Mortality - Daily from acclimatization of the animals to the termination of test.
Clinical signs - Daily from acclimatization of the animals to the termination of test.
Body weights - At start of acclimatization, on the day of application and at termination of observation.

The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and
72 hours, as well as 7, 10 and 14 days alter instillation.
Eye examinations were made with a Varia Cliptrix diagnostic-lamp.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
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:
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:
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
Irritant / corrosive response data:
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.67, 1.00 and 1.33 for reddening and 0.00 for chemosis for all three animals.
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
Moderate reddening of the conjunctivae was observed in all animals at the 1-hour reading.
Slight to moderate reddening of the conjunctivae was noted in all animals 24 hours after treatment. Slight reddening was present in all animals at the 48-hour reading and persisted in two animals up to 72 hours and in one animal up to 10 days after treatment.
Slight to moderate swelling was present in all animals at the 1-hour reading.
Moderate reddening of the sclerae was observed in all animals at the 1-hour reading and slight reddening was evident in two animals 24 hours after treatment and persisted in one animal up to the 48-hour examination. No ocular discharge was noted in any animal at any time.
No abnormal findings were observed in the treated eye of any animal 14 days after treatment, the end of the observation period for all animals.
No corrosion of the cornea was observed at any of the reading times.
Other effects:
Coloration : no staining of the treated eyes produced by the test item was observed
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
FEXO-03 is considered to be "not irritating" to the rabbit eye.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

These studies followed procedures indicated by internationally accepted guidelines and recommendations.


Justification for selection of skin irritation / corrosion endpoint:
This endpoint is judged as reliable because the test was performed in accordance with validated guidelines.

Justification for selection of eye irritation endpoint:
This endpoint is judged as reliable because the test was performed in accordance with validated guidelines.

Justification for classification or non-classification

According to Regulation EC 1272/2008 and to Directive 67/548/EEC, the substance should not be classified for the skin and eye irritation.