Registration Dossier

Administrative data

Description of key information

Skin irritation: in vivo, rabbit, Standard Draize test, 459 mg / 3d (RTECS): moderate reaction severity
Skin irritation: in vivo, rabbit, Standard Draize test, 100 mg / 24h (RTECS): moderate reaction severity
Skin irritation: Draize test, repeated 1h exposures (handbook): moderately irritating
Skin irritation: in vivo, California Albino or New Zealand White rabbit, semiocclusive, 0.5 mL (OECD 404): Draize score 4.3: moderately irritating
Eye irritation: in vivo, rabbit, Standard Draize test, 92 mg (RTECS): moderate reaction severity
Eye irritation: in vivo, rabbit, Standard Draize test, 20 mg / 24h (RTECS): moderately irritating
Eye irritation: in vivo (handbook): Draize score 40: moderately irritating
Eye irritation: in vivo, rabbit (handbook): moderately irritating
Eye irritation: in vivo, California Albino or New Zealand White rabbit, 0.1 mL (OECD 405): Draize score 40: moderately irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: publication
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Sufficiently documented publication, scientifically reasonable method, testing performed on the registered substance itself.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not applicable
GLP compliance:
no
Remarks:
conducted prior to GLP implementation
Species:
rabbit
Strain:
other: California Albino or New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: rabbitry at Point Reyes, Calif., or Gilroy laboratory, Calif.
- Weight at study initiation: 2 - 3 kg
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped: scarified or intact
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
min. 24h, max. 72h, as there is no data on removal of test substance
Number of animals:
no data
Details on study design:
TEST SITE
- Area of exposure: back and flanks of rabbits 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.
- Type of wrap if used: 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.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: mean of 24h and 72h
Score:
4.3
Reversibility:
no data
Remarks on result:
other: Scoring according to Draize (Draize JH: Procedures for the Appraisal of the Toxicity of Chemicals in Food, Drugs, and Cosmetics: VIII. Dermal Toxicity, Food, Drug, & Cos Law . 10:722, 1955)
Irritant / corrosive response data:
Moderate irritant
Interpretation of results:
other: moderately irritating (criteria used for interpretation of results: Draize scoring)
Conclusions:
The studied was conducted scientifically reasonable with sufficient documentation similar to OECD 404, it was assessed with Klimisch 2. Hence, the results are sufficiently reliable to assess the skin irritating properties of isopropyl glycidyl ether in rabbits. With an irritation score of 4.3, the substance is considered as moderate irritant according to Draize.
Executive summary:

In a primary dermal irritation study similar to OECD 404, male California Albino or New Zealand White rabbits were

dermally exposed to 0.5 mL of unchanged Isopropyl glycidyl ether for 24 hours to the untreated or scarified skin of the hips and shoulders.  Animals were observed for at least 72 hours.  Irritation was scored by the method of Draize.

In this study, Isopropyl glycidyl ether is a moderate dermal irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
other: publication
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Sufficiently documented publication, scientifically reasonable method, testing performed on the registered substance itself.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
GLP compliance:
no
Remarks:
conducted prior to GLP implementation
Species:
rabbit
Strain:
other: California Albino or New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: rabbitry at Point Reyes, Calif., or Gilroy laboratory, Calif.
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated second eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
no information given on wash-out after instillation
Observation period (in vivo):
at least 48 h
Number of animals or in vitro replicates:
no data
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Draize
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: mean after 1, 24, 48 h
Score:
40
Reversibility:
fully reversible
Remarks on result:
other: Scoring according to Draize (Draize JH: Procedures for the Appraisal of the Toxicity of Chemicals in Food, Drugs, and Cosmetics: VIII. Dermal Toxicity, Food, Drug, & Cos Law . 10:722, 1955)
Interpretation of results:
other: moderately irritating (criteria used for interpretation of results: Draize scoring)
Conclusions:
The studied was conducted scientifically reasonable with sufficient documentation similar to OECD 405, it was assessed with Klimisch 2. Hence, the results are sufficiently reliable to assess the eye irritating properties of isopropyl glycidyl ether in rabbits. With an irritation score of 40, the substance is considered as moderate irritant according to Draize.
Executive summary:

In a primary eye irritation study similar to OECD 405, 0.1 mL of unchanged Isopropyl glycidyl ether was instilled into the eye of male California Albino or New Zealand White rabbits. Animals then were observed for at least 48 h.  Irritation was scored by the method of Draize.

In this study, Isopropyl glycidyl ether is a moderate eye irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are four entries on skin irritation and five on eye irritation based on in vivo data available. Each topic contains a study report and database / handbook entries, which all consistently show that IPGE is moderately irritating to the skin / eye. There is no indication given that this result, commonly based on rabbit data, is not relevant for humans. Also, all results are consistent and derived i.a. from definitively reliable sources, hence, the database is of good quality. No data gaps were identified, and so no further testing is required.

Justification for classification or non-classification

All available data sources consistently reveal that IPGE is a moderate skin / eye irritant, providing a solid database. Although this classification is not mentioned in Regulation (EC) 1272/2008, the description of the effects match best the categories Irritating to skin (Category 2) and Irritating to eyes (Category 2); categories corrosive and not classified are not reasonable here.