[No public or meaningful name is available]

Endpoint summary

Description of key information

- Skin irritation / corrosion: not irritating (based on results of a reliable OECD 404 study for 'Paraffin Waxes (Fischer-Tropsch), full range, C15-50 - branched and linear')

- Eye irritation: not irritating (based on results of a reliable OECD 405 study for 'Paraffin Waxes (Fischer-Tropsch), full range, C15-50 - branched and linear')

- Respiratory irritation: The conclusion of not irritant to the respiratory tract is based on the absence of significant irritating effects on other membranes, specifically the 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:

13 November 2007 and 16 November 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: August 2007; Date of certificate: October 2007

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK.
- Age at study initiation: twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg.
- Housing:The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to mains drinking water and food (Certified Rabbit Diet) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Water (e.g. ad libitum):Free access to mains drinking water and food (Certified Rabbit Diet) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Acclimation period: Acclimatisation period of at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

IN-LIFE DATES: From:0 To:3

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
- Concentration (if solution): No Data

VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution):Not applicable
- Lot/batch no. (if required): Not applicable
- Purity:Not applicable

Duration of treatment / exposure:

5 hours

Observation period:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored.

Number of animals:

Three rabbits

Details on study design:

TEST SITE
- Area of exposure: On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. On the day of the test a suitable test site was selected on the back of each rabbit.
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Five hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure:Five hours after application.


SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4

Oedema Formation
Value
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

An isolated incident of very slight erythema was noted at one treated skin site at the 48-hour observation.
Two treated skin sites appeared normal throughout the study and the remaining treated skin site appeared normal at the 72-hour observation.

An isolated incident of very slight erythema was noted at one treated skin site at the 48-hour observation.

Two treated skin sites appeared normal throughout the study and the remaining treated skin site appeared normal at the 72-hour observation.

Deviation from protocol: Due to a technician error the animals were decontaminated one hour later than specified in the Protocol. This deviation was considered not to affect the purpose or integrity of the study.

Interpretation of results:

other: EU-GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as NON IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

§        OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted)

§        Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

Results. A single 5-hour, semi-occluded application of the test material to the intact skin of three rabbits produced an isolated incident of very slight erythema at one treated skin site. Two treated skin sites appeared normal throughout the study and the remaining treated skin site appeared normal at the 72-hour observation.

Due to a technician error the animals were decontaminated one hour later than specified in the Protocol. This deviation was considered not to affect the purpose or integrity of the study.

Conclusion. The test material produced a primary irritation index of 0.0 and was classified as non‑irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

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:

26 November 2007 and 06 December 2007.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: August 2007; Date of certificate: October 2007

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: At the start of the study the animals were in the weight range of 2.0 to 3.5 kg.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to mains drinking water and food (Certified Rabbit Diet) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Water (e.g. ad libitum): Free access to mains drinking water and food (Certified Rabbit Diet) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Acclimation period: Acclimatisation period of at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

IN-LIFE DATES: From:0 To:3

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and was used for control purposes.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye
- Concentration (if solution): No data

VEHICLE
- Amount(s) applied (volume or weight with unit):Not applicable
- Concentration (if solution):Not applicable
- Lot/batch no. (if required): Not applicable
- Purity:Not applicable

Duration of treatment / exposure:

72 Hours

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.

Number of animals or in vitro replicates:

Initially, a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No Data
- Time after start of exposure:No data

SCORING SYSTEM:
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

No corneal or iridial effects were noted.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24-hour observation.
All treated eyes appeared normal at the 24-hour observation.

Other effects:

None

IndividualScores and Individual Total Scoresfor Ocular Irritation

Rabbit Number and Sex	66812 Male				66869 Male				66870 Male
	IPR= 2				IPR = 2				IPR = 2
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours
CORNEA
E = Degree of Opacity	0	0	0	0	0	0	0	0	0	0	0	0
F = Area of Cornea Involved	0	0	0	0	0	0	0	0	0	0	0	0
Score (E x F) x 5	0	0	0	0	0	0	0	0	0	0	0	0
IRIS
D	0	0	0	0	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0	0	0	0	0
CONJUNCTIVAE
A = Redness	1	1	0	0	1	1	0	0	1	1	0	0
B = Chemosis	1	0	0	0	0	0	0	0	1	0	0	0
C = Discharge	1	0	0	0	1	0	0	0	1	0	0	0
Score (A + B + C) x 2	6	2	0	0	4	2	0	0	6	2	0	0
Total Score	6	2	0	0	4	2	0	0	6	2	0	0

 

Individual Total Scores and Group Mean Scoresfor Ocular Irritation

Rabbit Number and Sex	Individual Total Scores At:
	1 Hour	24 Hours	48 Hours	72 Hours
66812 Male	6	2	0	0
66869 Male	4	2	0	0
66870 Male	6	2	0	0
Group Total	16	6	0	0
Group Mean Score	5.3	2.0	0.0	0.0

Draize Scale for Scoring Ocular Irritation

1.	CONJUNCTIVAE
	(A)	Redness(refers to palpebral and bulbar conjunctivae excluding cornea and iris)
		Vessels normal		0
		Vessels definitely injected above normal		1
		More diffuse, deeper crimson red, individual vessels not easily discernible		2
		Diffuse beefy red		3
	(B)	Chemosis
		No swelling		0
		Any swelling above normal (includes nictitating membrane)		1
		Obvious swelling with partial eversion of lids		2
		Swelling with lids about half closed		3
		Swelling with lids half closed to completely closed		4
	(C)	Discharge
		No discharge		0
		Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)		1
		Discharge with moistening of the lids and hairs just adjacent to lids		2
		Discharge with moistening of the lids and hairs a considerable area around the eye		3
	THE TOTAL SCORE = (A + B + C) x 2		MAXIMUM TOTAL = 20
2.	IRIS
	(D)	Values
		Normal		0
		Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)		1
		No reaction to light, haemorrhage, gross destruction (any or all of these)		2
	THE TOTAL SCORE = D x 5		MAXIMUM TOTAL = 10
3.	CORNEA
	(E)	Degree of Opacity (most dense area used)
		No opacity		0
		Scattered or diffuse areas, details of iris clearly visible		1
		Easily discernible translucent areas, details of iris slightly obscured		2
		Opalescent areas, no details of iris visible, size of pupil barely discernible		3
		Opaque, iris not discernible through the opacity		4
	(F)	Area of Cornea Involved
		One quarter (or less) but not zero		1
		Greater than one quarter but less than half		2
		Greater than half but less than three quarters		3
		Greater than three quarters, up to whole area		4
	THE TOTAL SCORE = (E x F) x 5		MAXIMUM TOTAL = 80
	MAXIMUM TOTAL SCORE POSSIBLE = 110

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material produced a maximum group mean score of 5.3 and was classified as a MINIMAL IRRITANT (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

§        OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)

§        Method B.5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC

§        United States Environmental Protection Agency Health Effects Test Guidelines OPPTS 870.2400 Acute Eye Irritation August 1998

Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour observation.

Conclusion. The test material produced a maximum group mean score of 5.3 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Dermal irritation:

The study was performed to assess the irritancy potential of the test material following a single, 4-hour, semi-occluded application to the intact rabbit skin. The method was designed to meet the requirements of OECD Guideline No. 404 "Acute Dermal Irritation/Corrosion" and Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC.

No evidence of skin irritation or corrosion was observed during the study in three animals.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Eye irritation:

The study was performed to assess the irritancy potential of the test material following a single application to the rabbit eye. The method was designed to meet the requirements of OECD Guideline No. 405 "Acute Eye Irritation/Corrosion" and Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC.

A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour observation.

Justification for classification or non-classification

Skin / eye irritation: according to CLP classification criteria, the substance does not meet the criteria for classification and labelling for these endpoints, as set out in Regulation (EC) No. 1272/2008.