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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
October 1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
October 1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
The test item (Benzophenone-6 25% in corn oil) was administered in various doses to groups of 5 rats.
GLP compliance:
no
Remarks:
conducted prior to GLP implementation
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: albino Sherman-Wistar
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: 24h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
Route of administration:
oral: gavage
Vehicle:
other: test item is a 25% suspension of the registered substance in corn oil
Details on oral exposure:
test item is a 25% suspension of the registered substance in corn oil
Doses:
1, 2, 4, 8, 16 g/kg of a 25% suspension of the registered substance in corn oil
No. of animals per sex per dose:
5 / dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortalities, daily
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
act. ingr. is registered substance
Sex:
not specified
Dose descriptor:
LD0
Effect level:
>= 16 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortalities observed
Key result
Sex:
not specified
Dose descriptor:
LD0
Effect level:
>= 4 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: no mortalities observed
Remarks:
act. ingr. is registered substance
Mortality:
no mortalities observed
Clinical signs:
other: not stated
Gross pathology:
not stated

No mortalities observed in all dose groups at every observation time point.

Interpretation of results:
GHS criteria not met
Remarks:
EU implementation
Conclusions:
Given information indicates that the study was performed scientifically reasonable, so the results are considered sufficiently reliable to assess the acute toxicity of the registered substance in rats. No mortalities were observed up to the highest dose tested, i.e. 16 g/kg of a 25% suspension of the registered subtance in corn oil, so the relevant effective dose levels can be calculated for Benzophenone-6 to be LC50 > 4000 mg/kg, LD0 ≥ 4000 mg/kg, which is beyond the limit for classification as acutely toxic acc. Regulation 1272/2008 and amendments.
Executive summary:

When dosed as a 25% mixture in corn oil, the LD50 in white rats was found to be greater than 16 g/Kilo. (No fatalities observed at highest doses practicable).

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: FHSLA procedure
Version / remarks:
The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.
Deviations:
not specified
Principles of method if other than guideline:
0.1 ml / 100 mg of the test item were istilled into the eyes of rabbits
GLP compliance:
no
Remarks:
conducted prior to GLP implementation
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
none stated
Vehicle:
other: undiluted or 16, 8, or 4% in each dimethyl phthalate and petrolatum
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml / 100 mg
Duration of treatment / exposure:
no wash-out
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
at any observation timepoint or concentration
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
positive indication of irritation
Remarks:
at any observation timepoint or concentration
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
at any observation timepoint or concentration
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
at any observation timepoint or concentration
Irritant / corrosive response data:
The test material produced no discernible effects in the eyes of the rabbits.
Interpretation of results:
GHS criteria not met
Conclusions:
Given information indicates that the study was performed scientifically reasonable, so the results are considered sufficiently reliable to assess the irritating potential of the registered substance in rabbits. The information is given as overall mean irritation value including all four scores (cornea, iris, conjunctivae, chemosis), which was consistently zero, so these results may be used nevertheless for classification according to Regulation 1272/2008. As all values were zero over all observation time points, it can b ereasonably concluded that no classification as eye irritant according to Regulation 1272/2008 is triggered.
Executive summary:

The rabbit irritation test followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act. 0.1 ml of each of the six concentrations (16, 8, or 4% in each dimethyl phthalate and petrolatum) was instilled into the left eye of albino rabbits (six rabbits for each concentration). The eyes were not washed. No effects at all were observed.

In addition, when tested as the 100% powder (100 mg in right eye of each of six rabbits, unwashed, as above), no discernible effects were observed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSLA procedure
Version / remarks:
The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.
Deviations:
not specified
Principles of method if other than guideline:
Test item was applied as powder onto intact and abraded skin of rabbits.
GLP compliance:
no
Remarks:
conducted prior to GLP implementation

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-dihydroxy-4,4'-dimethoxybenzophenone
EC Number:
205-027-3
EC Name:
2,2'-dihydroxy-4,4'-dimethoxybenzophenone
Cas Number:
131-54-4
Molecular formula:
C15H14O5
IUPAC Name:
2-(2-hydroxy-4-methoxybenzoyl)-5-methoxyphenol
Test material form:
solid

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
none stated

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Remarks:
and 16, 8, and 4 % in each dimethyl phthalate and petrolatum
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100% powder
Duration of treatment / exposure:
The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.
Observation period:
The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.
Number of animals:
6
Details on study design:
The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
16% in dimethyl phthalate
Time point:
other: not specified
Score:
0.25
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
16% in petrolatum
Time point:
other: not specified
Score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
8% in both solvents
Time point:
other: not specified
Score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
4% in both solvents
Time point:
other: not specified
Score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Time point:
24/48/72 h
Remarks on result:
other: information not given
Irritation parameter:
edema score
Time point:
24/48/72 h
Remarks on result:
other: information not given

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Given information indicates that the study was performed scientifically reasonable, so the results are considered sufficiently reliable to assess the irritating potential of the registered substance in rabbits. The information is given as primary irritation index, which does not allow classification according to Regulation 1272/2008 in its classic sense. However, the regulation allows to retrieve information on classification also from other sources. As the PMII was consistently zero except once (0.25), it can be reasonably concluded that the substance would also not meet the classification criteria as set out in the regulation, so the substance can be considered non-irritating to the skin.
Executive summary:

The rabbit irritation test followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act. The substance was applied to intact and abraded rabbit skin undiluted, or as 16, 8, or 4% solution in each dimethyl phthalate and petrolatum. The substance was found to be non-irritating.