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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
Study period:
1996-11-04 to 1996-11-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted without any deviation.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-bis(hydroxymethyl)butanoic acid
EC Number:
424-090-1
EC Name:
2,2-bis(hydroxymethyl)butanoic acid
Cas Number:
10097-02-6
Molecular formula:
C6H12O4
IUPAC Name:
2,2-bis(hydroxymethyl)butanoic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): DMBA
- Physical state: White powder
- Analytical purity: 99 %
- Lot/batch No.: 5J01
- Date of receipt: 1996-10-09
- Expiration date of the lot/batch: Six months from receipt
- Storage condition of test material: Room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Interfauna (UK) Ltd, Huntingdon, Cambridgeshire, England.
- Age at study initiation: Approximately 13 weeks
- Weight at study initiation: 3.0-3.2 kg
- Housing: Animals were individually housed in metal cages with perforated floors.
- Diet: Standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: NA

ENVIRONMENTAL CONDITIONS
- Temperature: 17.5-22.5 °C
- Humidity: 40-73 %
- Air changes: Approximately 19 air changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: From: 1996-11-04 To: 1996-11-25

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 60 mg (the weight occupying a volume of 0.1 mL)

Duration of treatment / exposure:
Eyes were not rinsed throughout study
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize method

TOOL USED TO ASSESS SCORE: Hand-held light


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Not reversible in one rabbit
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: No effect observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Not reversible in one rabbit
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.89
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Fully reversible in two rabbits by 7 days
Irritant / corrosive response data:
- A single instillation of DMBA elicited corneal opacification and well defined to moderate conjunctival irritation in one rabbit: these effects persisted (without reduction, in the case of corneal opacity) until study termination, 21 days after treatment.
- However the other two rabbits showed markedly less reaction: no corneal effects were seen, and all conjunctival changes had resolved seven days after treatment.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

See attached document for information on tables of results

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, DMBA is classified as "Category 2 irritating to eyes" according to CLP Regulation (EC) N° (1272/2008).
Executive summary:

Test Guidance EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) guideline and in compliance with GLP. Method 3 New Zealand White female rabbits were exposed to 60 mg of DMBA in one eye while the contralateral eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined and the changes were observed at 1, 24, 48 and 72 hours and 4, 7 and up to 14 and 21 days after treatment and graded according to the Draize method. Result A single instillation of DMBA elicited corneal opacification and well defined to moderate conjunctival irritation in one rabbit, these effects persisted (without reduction, in the case of corneal opacity) until study termination, 21 days after treatment. However the other two rabbits showed markedly less reaction; no corneal effects were seen, and all conjunctival changes had resolved seven days after treatment. There were no signs of toxicity or ill health in any rabbit during the observation period. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 2.0, 0.0, 0.0 for cornea score; 0.0, 0.0, 0.0 for iris score; 2.7, 2.0, 2.0 for conjunctivae score and 2.3, 1.7, 1.7 for chemosis score. In this study, DMBA is an eye irritant on rabbits. Conclusion Under the test conditions, DMBA is classified as "Category 2 irritating to eyes" according to CLP Regulation (EC) N° (1272 /2008).

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