Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Basic information given
Justification for type of information:
Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions.
Justification for type of information:
Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: US Reg. (21 CFR 191.11)
Deviations:
no
GLP compliance:
no
Remarks:
study predates GLP
Specific details on test material used for the study:
- Name of test material: Boric acid
- Molecular formula: H3BO3
- Molecular weight: 61.8
- Smiles notation: B(OH)3
- Substance type: Inorganic
- Physical state: Solid
- Analytical purity: > 99.9 % w/w
- Stability under test conditions: Stable
- Other: White and odourless.
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: Six rabbits with intact and 6 rabbits with abraded skin. 5 mL of boric acid was applied as a 10 % solution on a cellulose pad.
- Concentration: 10 % solution
Duration of treatment / exposure: No data
Observation period: No data
Number of animals: 12

Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0.8
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
2.5
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
1.7
Max. score:
8
Reversibility:
other: no data
Remarks on result:
other: intact plus abraded skin
Other effects:
no data
Conclusions:
Interpretation of results: not irritating
Remarks: Migrated information Criteria used for interpretation of results: not specified
Conclusions:Not irritating

Data source

Reference
Reference Type:
publication
Title:
Safety evaluation of some humectants and moisturizers used in cosmetic formulations.
Author:
Guillot JP, Martini MC, Giauffret JY, Gonnet JF, Guyot JY
Year:
1982
Bibliographic source:
International Journal of Cosmetic Science 4: 67-80

Materials and methods

Principles of method if other than guideline:
Draize Test: test procedure as described in the Journal Officiel de la République Francaise
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: about 2.5 kg
- Housing: in individual cages
- No further details provided

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0,5 ml
Duration of treatment / exposure:
23
Number of animals:
6
Details on study design:
Details on study design:
TEST SITE
- Area of exposure: 4 cm x 4 cm; application area with and without scarification
- Type of wrap if used: occlusive patches "Neodermotest", fixed using absorbent gauze held in place by adhesive tape.

SCORING SYSTEM: Draize-score system; determination of the primary cutaneous irritation index.
- The substance was considered to be a non irritant if the score was less than 0.5
- The substance was considered to be slightly irritant if the score was between 0.5 and 2.0

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other:
Remarks:
mean max cutaneous index
Basis:
mean
Time point:
other: No data
Score:
ca. 0.04
Remarks on result:
other: Undiluted DEG
Irritation parameter:
other:
Remarks:
mean max cutaneoud index
Basis:
mean
Time point:
other: six weeks
Score:
ca. 0.47
Remarks on result:
other: undiluted DEG
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: six weeks
Score:
ca. 0
Remarks on result:
other: 10% sol. in water
Irritant / corrosive response data:
Undiluted DEG: PII: 0.04; 6 -week cumulative cutaneous irritation: well tolerated (MMII = 0.47)
10% solution: 6 -week cumulation cutaneous irritation: very well tolerated (MMII = 0)

PII = primary cutaneous irritation index;
MMII = mean maximum cutaneous index.

Any other information on results incl. tables

In their pure form, humectants are particularly well tolerated in primary cutaneous irritation for nearly all these indices approximate to 0 and so correspond to a non-irritant application.

Applicant's summary and conclusion

Conclusions:
GHS criteria for classification not met