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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 09 to 18 Feb 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(S)-5-fluoro-3-methylisobenzofuran-1(3H)-one
EC Number:
943-180-4
Cas Number:
1803573-19-4
Molecular formula:
C9H7FO2
IUPAC Name:
(S)-5-fluoro-3-methylisobenzofuran-1(3H)-one
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
Batch No.: E010016692Purity: 99.3%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Charles River France, L’Arbresle, France- Age at study initiation: between 12 and 24 weeks old- Weight at study initiation: at least 1.5 kg- Housing: Animals were individually housed in labeled cages with perforated floors and shelters.- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay and wooden sticks were available during the study period.- Water (e.g. ad libitum): Free access to tap water.- Acclimation period: at least 5 days before start of treatmentENVIRONMENTAL CONDITIONS- Temperature (°C): 18 to 24- Humidity (%): 40 to 70- Air changes (per hr): at least 10 air changes/hour- Photoperiod (hrs dark / hrs light): a 12-hour light/12-hour dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 grams of the test substanceVEHICLE- Amount(s) applied (volume or weight with unit): 0.3 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE- Area of exposure: 2x3 cm- Type of wrap if used: metalline patch mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.REMOVAL OF TEST SUBSTANCE- Washing (if done): tap water- Time after start of exposure: Four hoursOBSERVATION:-Mortality/Viability: Twice daily. -Toxicity: At least once daily. -Body Weight: Day of treatment (prior to application) and on the day of the final observation-Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test item.The irritationscores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.-Necropsy: No necropsy was performed according to study plan.SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
No skin irritation was caused by 4 hours exposure to test substance.There was no evidence of a corrosive effect on the skin.
Other effects:
No staining of the treated skin by the test item was observed and no test item remnants were seen.No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Individual skin irritation scores:

Animal

6

15

16

Time after exposure

Erythema

(0-4)

Oedema

(0-4)

Erythema

(0-4)

Oedema

(0-4)

Erythema

(0-4)

Oedema

(0-4)

1 hour

0

0

0

0

0

0

24 hours

0

0

0

0

0

0

48 hours

0

0

0

0

0

0

72 hours

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results the test substance does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).