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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Meets generally accepted scientific standards, well documented and acceptable for assessment. No Purity of test substance available. No scores for the 48 h time point recorded, however, since all scores at 24 and 72 hours were 0, this deficiency is considered not to affect the interpretation of the study results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: AFDO (1959) Appraisal of the safety of chemicals in Foods, Drugs and cosmetics.
Principles of method if other than guideline:
Draize test: Three male and three female rabbits were treated with a gauze patch, soaked with the test substance (0.5 g). The animals were treated with intact and scarificed skin for 24 h under occlusive conditions. The skin reactions were evaluated 24 h and 72 h after removal of test substance.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]
EC Number:
265-512-0
EC Name:
Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]
Cas Number:
65140-91-2
Molecular formula:
C17 H29 O4 P. 1/2Ca
IUPAC Name:
calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
Weight: 1.5-2 kg
Diet: NAFAG, Gossau SG, rabbit food, ad libitum
Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 50% polyethylene glycol
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
3 per sex
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch covered with a plastic film

SCORING SYSTEM: Draize scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: scarified skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: scarified skin
Irritant / corrosive response data:
A mild erythema was observed in 4/6 animals at the 24 hour time point when tested on scarified skin (average score = 0.67), reversible within 72 hours. Intact skin did not elicit any reaction after treatment, all scores for edema and erythema were zero for all time points in all animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Based on the results of the study and under the test conditions chosen, the test article is considered to be not irritating to the rabbir skin.
Executive summary:

In a skin irritation study three male and female rabbits were treated occlusively with the test article for 24 hours. The test article was applied to scarified and intact skin on the back of the rabbits on a gauze patch covered with a plastic film and held in place with an adhesive tape. 50% PEG served as vehicle. The reaction of the skin was appraised upon removal and 72 hours after. No scores were recorded for the 48 hour time point. All scores for the intact skin were zero for edema and erythema in all animals at any recorded time point. A mild erythema was observed in 4/6 animals at the 24 hour time point when tested on scarified skin (average score = 0.67), reversible within 72 hours. Findings on scarified skin have not been taken into account for the calculation of erythema and edema scores, due to current regulations according to which only findings on intact skin are reliable for assessing the skin irritation potential of a test substance. Based on the data provided by this study report, the test article is considered to be not irritating to rabbit skin.