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Diss Factsheets

Administrative data

Description of key information

The skin irritation/corrosion study was performed according to OECD Guideline 404 and GLP principles and the eye irritation/corrosion study was performed according to OECD Guideline 405 and GLP principles

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:
August 28 - September 14, 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
Principles of method if other than guideline:
United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.2500, Acute Dermal Irritation. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-98-196, August 1998. Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
other: The test substance was applied undiluted as delivered by the sponsor.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days.
Other effects:
Sticky and dry remnants of the test substance were present
on the skin on Day 1.

No staining of the treated skin by the test substance was
observed.
Interpretation of results:
other: Not classified.
Remarks:
According to Regulation (EC) 1272/2008
Conclusions:
Reaction products of Fatty acids, C16-18 and C18-unsatd. and reaction mass of 1,3-alkanediol, 2-(hydroxymethyl)-2-[(methoxymethoxy)methyl]- and 1,3-heteromonocycle-5,5-dimethanol does not have to be classified and has no obligatory labelling requirement for skin irritation.
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:
September 03-15, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.2400, Acute Eye Irritation. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-98-195, August 1998. Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
.1 ML
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
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
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
Irritation of the conjuncitvae, consisting of redness, chemosis and discharge was observed. This had resolved within 24 hours in one animal and wihtin 48 hours in the other two animals.
Other effects:
No staining of (peri) ocular tissues by the test substance
was observed and no test substance remnants were seen.
Interpretation of results:
other: Not classified.
Remarks:
According to Regulation (EC) 1272/2008
Conclusions:
Reaction products of Fatty acids, C16-18 and C18-unsatd. and reaction mass of 1,3-alkanediol, 2-(hydroxymethyl)-2-[(methoxymethoxy)methyl]- and 1,3-heteromonocycle-5,5-dimethanol does not have to be classified and has no obligatory labelling requirement for eye irritation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

In a skin irritation study performed according to OECD, EC, EPA and JMAFF test guidelines, three rabbits were exposed to 0.5 g of substance semi-occlusively for 4 hours. Skin reactions were assessed 1, 24, 48 and 72 hours, 7 and 14 days after exposure.

Exposure to Radia 7853 resulted in some slight irritation with mean scores at 24 -48 -72 hours calculated for all three animals of 0.7 for each animal and for erythema 0.7, 0, and 0.3 for each animal for edema. These effects had resolved within 3 days after exposure in all animals. Sticky and dry test substance remnants were present on the skin on Day 1. No staining of the treated skin by the test substance was observed. Therefore, Radia 7853 is considered to be not skin irritating.

Eye:

In an eye irritation study performed according to OECD, EC, EPA and JMAFF test guidelines, three rabbits were exposed to 0.1 ml of substance. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 24 hours in one animal, and within 48 hours in the other two animals. Therefore, Radia 7853 is considered not eye irritating.

Justification for classification or non-classification

Based on the available data, the substance does not have to be classified for skin and eye irritation according to CLP Regulation (EC) No 1272/2008.