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Diss Factsheets

Administrative data

Description of key information

In GLP in vivo guideline studies with rabbits, the substance was found to be essentially non-irritating to skin and eyes. The substance does not meet the requirements for classification as corrosive/irritating to skin or damaging/irritating to eyes.

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:
29 August 2017 thru 1 September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
CASNo.: 13171-18-1
Lot #: HFMOP17004
Storage: Room Temp.
Purity: >99.99%
Description: Clear Liquid
pH: Neutral molecule
Stability: Expected to be stable for the duration of testing.
Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or test system and environmental conditions:
ANIMALS:
Sex: Female, nulliparous and non-pregnant.
Age: Young adult (12 weeks)
Weight: 2358 - 2651 grams at experimental start
Source: Received from Robinson Services, Inc. on 23 August 2017

HUSBANDRY:
Stainless steel cages with enrichment (e.g. toy), litter paper changed at least three times per week.
Temp: 20 - 23 deg C and 51 - 70% relative humidity
Photoperiod: 12-hour light/dark cycle
Acclimitization Period: 6 days
Food: Envigo Teklad Global High Fiber Rabbit Diet #2031; 150 g/day along with a Premium Timothy Cube
Water: Filtered tap ad libitum

IDENTIFICATION:
Each cage was identified with a cage card indicating at least the study number and the ID and sex of the animal.
Each animal was given a unique ID number that was attached via stainless steel ear tag.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml applied to 6 cm2 intact dose site.
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk.
- % coverage: 6 cm2
- Type of wrap if used: 1 x 1 guaze pad and 3-inch Micropore tape that covered the pad and entire trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 3% soap solution followed by a tap water rinse and a clean paper towel.
- Time after start of exposure: 4 hours.

OBSERVATION TIME POINTS
- 30 to 60 minutes; 24 hours, 48 hours, and 72 hours after patch removal.

SCORING SYSTEM:
- Draize et al. 1944 and Primary Dermal Irritation Index (PDII) as follows; 0 = non irritating; >0 - 2.0 = Slightly irritating; 2.1 - 5.0 = Moderately irritating; >5.0 = Severely irritating.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
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:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
The overall Primary Derminal Index (PDII) score = 0.6; slightly irritating.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was only slighly irritating in 2 of 3 animals at the 24-hour observation mark. No signs of irritation remained at the 48 hour observation time.
Executive summary:

In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2500 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 2 of 3 animals at the 24-hour observation mark. No signs of irritation remained at the 48 hour observation time. Therefore, the substance was determined to not meet the criteria for classification as corrosive or irritating to the 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
CASNo.: 13171-18-1
Lot #: HFMOP17004
Storage: Room Temp.
Purity: >99.99%
Description: Clear Liquid
pH: Neutral molecule
Stability: Expected to be stable for the duration of testing.
Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or tissues and environmental conditions:
ANIMALS:
Sex: Female, nulliparous and non-pregnant.
Age: Young adult (12 weeks)
Weight: 2400 - 2741 grams at experimental start
Source: Received from Robinson Services, Inc. on 23 August 2017

HUSBANDRY:
Stainless steel cages with enrichment (e.g. toy), litter paper changed at least three times per week.
Temp: 20 - 23 deg C and 68 - 74% relative humidity
Photoperiod: 12-hour light/dark cycle
Acclimitization Period: 6 days
Food: Envigo Teklad Global High Fiber Rabbit Diet #2031; 150 g/day along with a Premium Timothy Cube
Water: Filtered tap ad libitum

IDENTIFICATION:
Each cage was identified with a cage card indicating at least the study number and the ID and sex of the animal.
Each animal was given a unique ID number that was attached via stainless steel ear tag.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
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): No
- Time after start of exposure: N/A

SCORING SYSTEM: Draize et. al. 1994.

TOOL USED TO ASSESS SCORE: White light source and fluorescein dye.
Irritation parameter:
cornea opacity score
Basis:
animal: 1 thru 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 1 thru 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 1 thru 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 1 thru 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was only slightly irritating in 1 test animal at the 1 hour observation time. This response cleared up by the 24 hour observation time. There were no signs of irritation at the 24, 48, or 72 hour observation times in any of the test animals.
Executive summary:

In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2400 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 1 of 3 animals at the 1-hour observation mark. No signs of irritation remained at the 24 hour observation time and there were no signs of irritation in any of the test animals at the 24, 48, or 72 hour observation times. Therefore, the substance was determined to not meet the criteria for classification as damaging or irritating to the eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2500 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 2 of 3 animals at the 24-hour observation mark. No signs of irritation remained at the 48 hour observation time. Therefore, the substance was determined to not meet the criteria for classification as corrosive or irritating to the skin.

In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2400 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 1 of 3 animals at the 1-hour observation mark. No signs of irritation remained at the 24 hour observation time and there were no signs of irritation in any of the test animals at the 24, 48, or 72 hour observation times. Therefore, the substance was determined to not meet the criteria for classification as damaging or irritating to the eye.