Reaction products of 2-(chloromethyl)oxirane and glycerol

Endpoint summary

Description of key information

Teh registered substance is strongly irritating to eyes and skin, with possible risks of irreversible effects (Ash, 2-nd Edition, 2007).

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed handbook

Principles of method if other than guideline:

As this is data from a peer-reviewed handbook, no details are given on the methods or the guidelines followed.

GLP compliance:

not specified

Species:

other: not given

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Amount / concentration applied:

no details given

Duration of treatment / exposure:

no details given

Observation period:

no details given

Details on study design:

no details available

Reversibility:

not reversible

Remarks on result:

other: strongly irritating to eyes and skin, possible risks of irreversible effects

Interpretation of results:

other:

Remarks:

Category 2 (irritant) based on EU GHS criteria

Conclusions:

No information is available concerning animals or methods used, guidelines followed. However, as the information comes from a peer-reviewed handbook, the information is considered to be of the high quality (reliability Klimisch 2). For the test material it is stated that the substance is strongly irritating to eyes and skin, with possible risks of irreversible effects. The test material does require classification, according to regulation (EC) 1272/2008.

Executive summary:

The Handbook of Filler, Extenders, and Diluents also gives some information about 1,2,3 -propanetriol, glycidyl ethers (Handbook of Filler, Extenders, and Diluents, Ash, 2.nd Edition, 2007). There is stated that the substance is strongly irritating to eyes and skin, with possible risks of irreversible effects. No further details are given.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed handbook

Principles of method if other than guideline:

As this information comes from a peer-reviewed handbook, no information is available on i.e. the methods and on the guidelines followed.

GLP compliance:

not specified

Species:

other: not given

Irritation parameter:

other: effects on eyes

Reversibility:

other: possible risks of irreversible effects

Remarks on result:

other: strongly irritating to eyes and skin

Irritant / corrosive response data:

strongly irritating to eyes and skin, possible risks of irreversible effects

Interpretation of results:

other: Category 2 (irritating) based on EU GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

Conclusions:

No information is available concerning animals or methods used, guidelines followed. However, as the information comes from a peer-reviewed handbook, the information is considered to be of the high quality (reliability Klimisch 2). For the test material it is stated that the substance is strongly irritating to eyes and skin, with possible risks of irreversible effects. The test material does require classification, according to regulation (EC) 1272/2008.

Executive summary:

The Handbook of Filler, Extenders, and Diluents also gives some information about the eye irritating potential of 1,2,3 -propanetriol, glycidyl ethers (Handbook of Filler, Extenders, and Diluents, Ash, 2.nd Edition, 2007). There is stated that the substance is strongly irritating to eyes and skin, with possible risks of irreversible effects. No further details are given.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation

Data on 1,2,3 - propanetriol, glycidyl ethers (GE-100)

 

The "Handbook of Filler, Extenders, and Diluents" gives some information about the skin irritating potential of 1,2,3 -propanetriol, glycidyl ethers (Ash, 2-nd Edition, 2007). There is stated that the substance is strongly irritating to eyes and skin, with possible risks of irreversible effects. No further details are given. However, the acute dermal toxicity study conducted with 1,2,3 - propanetriol glycidyl ethers indicate that no cutaneous reactions were observed in treated animals after 24 -h dermal exposure (Manciaux, 1998, see section 5.2.1.3 of the CSR or section 7.2.3.of IUCLID file). Taken together there results and considering supporing data available on read-across substances (see below), strongly indicate that the registered substance is irritating to the skin.

 

Data on read across substances:

Data on Polyglycidyl Ether of Substituted Glycerin (EPON 562)

 

The skin irritation potential of polyglycidyl ether of substituted glycerine (EPON 562) was investigated by Hine et al. (1958). The test material was administered semiocclusively to rabbits (male Albino). The rabbits were clipped over the back and flanks, and four areas of the back designated for the test, two intact and two scarified with wire mesh. The animals were immobilized in a multiple rabbit holder, and patches of gauze were secured over the areas with adhesive tape. The compound was introduced under the patches, and the entire trunk of the rabbits enveloped in rubber dam. After 24 hours the rabbits were released, the resin removed, and a first reading made. After 72 hours a second reading was made. EPON 562 was moderately irritating, with a score of 5.

The "Patty´s Industial Hygiene and Toxicology" also contains information about Polyglycidyl ether of substituted glycerine (Hine et al., 1981). It is mentioned, that a score of 0 was obtained by the Draize test for a single application. The compound is classified as non-irritating by this method.

 

Data on glycidol, allyl glycidyl-, n-butyl glycidyl-, isopropyl-, phenyl glycidyl ethers and diglycidyl ether

 

The skin irritation of glycidol and five related ethers - allyl glycidyl ether, n-butyl glycidyl ether, diglycidyl ether, isopropyl glycidyl ether and phenyl glycidyl ether - was evaluated experimentally in California Albino or New Zealand White rabbits (Hine et al., 1956). The back and flanks of rabbits (2 to 3 kg) were clipped 24 hours prior to use. The shoulders and hips were used as test sites, two areas on each animal being scarified and two intact. A patch consisting of three layers of gauze was secured over each area with adhesive tape and 0.5 mL of the undiluted compound was introduced under the gauze. The rabbits were wrapped in towels and immobilised for 24 hours, after which the areas were examined and irritation scores noted.The skin reactions were evaluated according to the method of Draize.A second reading was made at 72 hours. The average of all readings was used as the basis for grading the compound. BGE and PGE were mildly irritating and DGE would be considered severe (score 7.5 out of 8). The other glycidyl ethers were moderate irritating. The maximum injury score for erythema was obtained in some rabbits with all compounds except PGE, however. The personal experience of laboratory personnel working with theses compounds confirmed the observation that DGE was by far the most irritating of the compounds in skin contact. The skin irritation values were given for glycidol (mean average score: 4.5, moderate), for allyl glycidyl ether (mean average score 4, moderate ), for n-butyl glycidyl ether (mean average score 2.8, mild), for diglycidyl ether (mean average score 7.5, severe), for isopropyl glycidyl ether (mean average score 4.3, moderate) and for phenylglycidyl ether (mean average score 0.7, mild).

 

Eye irritation

 

Data on 1,2,3 - propanetriol, glycidyl ethers (GE-100)

 

The Handbook of Filler, Extenders, and Diluents gives some information about the skin irritating potential of 1,2,3 -propanetriol, glycidyl ethers (Ash, 2-nd Edition, 2007). There is stated that the substance is strongly irritating to eyes and skin, with possible risks of irreversible effects. No further details are given. These information together with further supporting data on read-across substances (see below) indicates that the registered substance is irritating to the eye.

 

Data on read across substances

Data on Polyglycidyl Ether of Substituted Glycerin (EPON 562)

 

The eye irritation potential of polyglycidyl ether of substituted glycerine (EPON 562) was investigated by Hine et al.(1958). The irritating effect was tested on rabbit (male Albino) eyes by dropping 0.1 mL of a 20% suspension in propylene glycol on the centre of the cornea. Readings were made at 1, 24, and 48 hours, with the corneas unstained and then stained with a 2% solution of fluorescein sodium. Injury was scored according to the method of Draize. EPON 562 was severely irritating to rabbit eyes (score 82 of maximum 120).

The "Patty´s Industrial Hygiene and Toxicology" also contains information about the eye irritating properties of 1,2,3 -propanetriol, glycidyl ethers (Hine et al., 1981). It is mentioned, that the substance, when administered to the eyes in a Draize test, a score of 82 was obtained.

 

Data on glycidol, allyl glycidyl-, n-butyl glycidyl-, isopropyl-, phenyl glycidyl ethers and diglycidyl ether

 

The eye irritation of glycidol and five related ethers - allyl glycidyl ether, n-butyl glycidyl ether, diglycidyl ether, isopropyl glycidyl ether and phenyl glycidyl ether - was evaluated experimentally in California Albino or New Zealand White rabbits (Hine, 1956). Normal rabbit eyes were preselected on the basis of absence of grossly visible staining by a 5% aqueous solution for fluorescein sodium, flushed with distilled water 20 seconds after instillation. After a two-hour interval, to allow the eyes to return to normal, 0.1 mL of an undiluted compound was instilled into one eye, leaving the other for a control. The liquids were dropped on the centre of the cornea, while the lids were retracted; about one minute later the lids were released. Readings were made at 1, 24, and 48 hours an then averaged as a basis for grading the compound.There was a marked difference in the eye-irritating properties of BGE and PGE in comparison with the other ethers and glycidol. These two compounds were only mildly irritating, while severe irritation was caused in individual rabbits by all four of the other compounds, and three of them - glycidol, DGE and AGE - had average scores, indicating them to be severe irritants. However, despite the severity of primary injury, no blindness or permanent defects in the cornea, lens, or iris resulted from the applications.The compounds are very irritating to the eyes, and proper precautions should be instituted to prevent droplet contact. The eye irritation values were given for glycidol (mean average score: 68, severe), for allyl glycidyl ether (mean average score 72, severe ), for n-butyl glycidyl ether (mean average score 4, mild), for diglycidyl ether (mean average score 74, severe), for isopropyl glycidyl ether (mean average score 40, moderate) and for phenylglycidyl ether (mean average score 8, mild).

 

Justification for selection of skin irritation / corrosion endpoint:
The study result originates from a well documented publication which meets basic scientific principles.

Justification for selection of eye irritation endpoint:
The study result originates from a well documented publication which meets basic scientific principles

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation:

The body of evidence points to an irritating potential of 1,2,3 - propanetriol glycidyl ethers.

According to the European regulation (EC) No. 1272/2008, the test material does meet the criteria for classification and will require labelling as irritating to the skin (Warning, Category 2, H315: causes skin irritation). However, the substance did not produce cutaneous reactions in rats exposed during 24 hour in the acute dermal toxicity study (Manciaux, 1998). It is very likely that the substance induces only minimal dermal irritation.

 

Eye irritation:

According to the European regulation (EC) No. 1272/2008, the test material does meet the criteria for classification and will require labelling as irritating to eyes (Warning, Category 2, H319 : causes serious eye irritation).