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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a GLP guideline study. Study was conducted in accordance to GLP and OECD guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentaerythritol, propoxylated
EC Number:
500-030-9
EC Name:
Pentaerythritol, propoxylated
Cas Number:
9051-49-4
Molecular formula:
(C3 H6 O)n (C3 H6 O)m (C3 H6 O)x (C3 H6 O)y C5 H12 O4 1 < (n + m + x + y) < 8.5
IUPAC Name:
12,12-bis[(2-hydroxypropoxy)methyl]-5,8,16,19-tetramethyl-4,7,10,14,17,20-hexaoxatricosane-2,22-diol; 12-[(2-hydroxypropoxy)methyl]-12-{[2-(2-hydroxypropoxy)propoxy]methyl}-5,8,16-trimethyl-4,7,10,14,17-pentaoxaicosane-2,19-diol; 9,9-bis({[2-(2-hydroxypropoxy)propoxy]methyl})-5,13-dimethyl-4,7,11,14-tetraoxaheptadecane-2,16-diol
Details on test material:
Pentaerythritol, propoxylated, (Molecular weight Mn = 420 g/mole)
Lot No. 0024
Storage: Room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye was used as control
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
Not Rinsed


SCORING SYSTEM: Kay and Calandra classification system


TOOL USED TO ASSESS SCORE: Standard Opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Minimal  conjunctival irritation was noted in all treated eyes one hour after  treatment. All treated eyes appeared normal at the 24-hour observation.  According to EU classification criteria, the test substance is not an eye  irritant.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 4.0 and was classified as minimal irritant (Class 3 on A 1 to 8 scale) to the rabbit eye according to Kay and Calandra classification system. The effects observed do not warrant classification in the EU.