Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30-10-2002 to 06-11-2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. All relevant validity criteria were met.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
inspected: February 2000; signature: April 2000

Test material

Constituent 1
Reference substance name:
2-Ethyl-4,4-dimethyl-1,3-oxathiane
IUPAC Name:
2-Ethyl-4,4-dimethyl-1,3-oxathiane
Test material form:
liquid
Details on test material:
- Physical state: liquid
- Storage condition of test material: approximately 4°C in the dark, under nitrogen
- Other: Colourless.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: recognised animal supplier
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: Individually housed in suspended metal cages.
- Diet: certified rabbit diet ad libitum
- Water: mains drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod: 12 hours light / 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): Test material was used as supplied.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, Four 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: 4 hours

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema ................. ....... ... ...... ... ........ .... .. ... .... ..... ..... ...... ...... ... .......... ........... .. .. .0
Very slight erythema (barely perceptible) ... .................... .. .... ....... .......... .. .................... .1
Well-defined erythema .............. ....... .. .................. ....... ... .. ... .... .... ........... ... ............ .... ..2
Moderate to severe erythema ............... ... .. .................. .... .... ...... .... ........... ... ............ .....3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) .. .. ........4

Oedema Formation
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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72h
Score:
0.25
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 day
Score:
0
Max. score:
4
Remarks on result:
other: Slight desquamation in one organism observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 day
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Very slight erythema was noted at all treated skin sites one hour after patch removal with very slight to well-defined erythema at the 24 and 48-hour observations and very slight erythema at one treated skin site at the 72-hour observation. Very slight oedema was noted at all treated skin sites at the 24-hour observation and at two treated skin sites at the 48-hour observation. Slight desquamation was noted at one treated skin site at the 7 -day observation. Two treated skin sites appeared normal at the 72-hour observation.
Other effects:
- Other adverse local effects: Sliqht desquamation at day 7 in #2. Applicant assessment indicates that this would have resolved by day 14 by expert judgement.
- Other adverse systemic effects: None reported.

Any other information on results incl. tables

Table 1. Individual skin reactions

Skin reaction Observation time Individual score - Rabbit number
1 2 3
Erythema 1 hour 1 1 1
24 hours 2 2 1
48 hours 1 2 1
72 hours 0 1 0
7 Days 0 0 D 0
Oedema  1 hour 0 0 0
24 hours 1 1 1
48 hours 1 1 0
72 hours 0 0 0
7 Days 0 0 0

D - desquamation

Mean scores per organism at 24, 48 and 72h:

Erythemea/Escar Formation:

1: total = 3; mean score = 1.0

2: total = 5; mean score = 1.7

3: total = 2; mean score = 0.7

Oedema Formation:

1: total = 2; mean score = 0.7

2. total = 2; mean score = 0.7

3. total = 1; mean score = 0.3

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test item is not considered to be irritating to the skin.
Executive summary:

The study was performed to EU Method B.4 and OECD 404 to assess the primary skin irritancy potential of the test item in accordance with GLP in New Zealand White rabbits. 0.5 ml of the test item was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period. After 4 hours of exposure to the test item, the pads and collars were removed and the test sites were gently cleaned of any residual test item with distilled water. Individual dose sites were scored according to the Draize scoring system at approximately 1, 24, 48, and 72 hours and at 7 days after patch removal. Very slight erythema was noted at all treated skin sites one hour after patch removal with very slight to well-defined erythema at the 24 and 48-hour observations and very slight erythema at one treated skin site at the 72-hour observation. Very slight oedema was noted at all treated skin sites at the 24-hour observation and at two treated skin sites at the 48-hour observation. Slight desquamation was noted at one treated skin site at the 7-day observation. Two treated skin sites appeared normal at the 72-hour observation. Under the conditions of this study the substance is not classified as irritating to the skin.