Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP conditions
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
2007-10-15
Specific details on test material used for the study:
Name: 2,2’ -Dihydroxy-4-methoxybenzophenone
Batch/Lot Number: 8010111
Description:Yellow powder
Expiry Date: 26 August 2008
Storage Conditions: Room Temperature in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually housed in suspended cages; the animals were provided with environmental enrichment items
- Diet: free access, 2030 Teklad Global Rabbit diet supplied by Harlan Teklad)
- Water: free access
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12h
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5g
VEHICLE
- Amount(s) applied: 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Type of wrap: elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing: removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1h, 24h, 48h and 72h

SCORING SYSTEM:
- Method of calculation: Draize JH 1959
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No evidence of skin irritation was noted during the study.
Other effects:
All animals showed expected gain in bodyweight during the study.

Skin reaction

Observation time

Individual scores – rabbit number and sex

Total

Animal 1 Male

Animal 2 Male

Animal 3 Male

Erythema/Eschar Formation

1 Hour

24 Hours

48 Hours

72 Hours

0

0

0

0

0

0

0

0

0

0

0

0

(0)

0

(0)

0

Oedema Formation

1 Hour

24 Hours

48 Hours

72 Hours

0

0

0

0

0

0

0

0

0

0

0

0

(0)

0

(0)

0

Sum of 24 and 72-hour readings: 0

Primary irritation index (S/6): 0/6 = 0.0

Classification: NON IRRITANT

Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as Non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Executive summary:

2,2 -Dihydroxy-4 -methoxybenzophenone was tested according to OECD Test guideline 404 and GLP criterias for its skin irritation potential.

For all three animals, irritation scores were of 0. The test substance is not irritating to the skin of rabbits.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
pH measurement performed before skin irritaiton assessment of the test substance.
GLP compliance:
yes (incl. certificate)
Remarks:
2007-10-15

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Name: 2,2’ -Dihydroxy-4-methoxybenzophenone
Batch/Lot Number: 8010111
Description:Yellow powder
Expiry Date: 26 August 2008
Storage Conditions: Room Temperature in the dark

Reagents

Reagent:
water

Results and discussion

pH value
pH value:
8.1
Concentration:
10 other: % w/w

Any other information on results incl. tables

10 % w/w aqueous prepration of the test material: pH measured was 8.1 immediately and after 10 minutes.

Applicant's summary and conclusion

Conclusions:
The test item has a pH of 8.1 when prepared to a 10% w/w aqueous solution.
Executive summary:

2,2'-Dihydroxy-4 -methoxybenzophenone has a pH of 8.1 when prepared to a 10% w/w aqueous solution.