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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
Study period:
23 Oct-01 Nov 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.5.
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Adopted 24 Feb 1987
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Good Laboratory Practice, The United Kingdom Compliance, Programme, Department of Health & Social Security 1986 and subsequent revision, Department of Health 1989.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
EC Number:
212-990-3
EC Name:
2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
Cas Number:
903-19-5
Molecular formula:
C22H38O2
IUPAC Name:
2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River UK, Ltd., Margate, Kent, UK
- Age at study initiation: 13-15 weeks old
- Weight at study initiation: 2.9-3.4 kg (range)
- Housing: individually, in plastic cages with perforated floors
- Diet: SDS Stanrab (P) rabbit diet, ad libitum
- Water: drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~19
- Humidity (%): 30-70
- Air changes (per hr): ~19
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 23 Oct 1995 To: 01 Nov 1995

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 66.6 mg or 0.1 mL
- Concentration: neat, as Sponsor supplied
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48, 72, 96 h and 7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: single exposure without washing
- Time after start of exposure: 1, 24, 48, 72, 96 h and 7 days after instillation.

SCORING SYSTEM:
Ocular irritation was assessed using a numerical system (based on the Draize system of grading) that evaluated and produced a numerical grade for: corneal opacity (degree of density), iris (appearance and reaction to light), conjunctivae (redness and blood vessels appearance), and chemosis (swelling of eye lids and nictitating membranes).

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Remarks:
at 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
At initial instillation there was transient mild conjunctival reaction scores:
1 for chemosis (any swelling [including nictitating membranes] above normal); and 1 for redness (some blood vessels definitely hyperaemic / injected) in 3 of 3 animals.
Conjunctival redness (score of 1) was recorded at 24 h in 1 rabbit only; and was fully reversible within 48 h.
Corneal opacity and iritis were recorded with scores of 0.0 at all reading time points of 1, 24, 48, 72 h and 4 and 7 days after instillation, in 3 of 3 animals.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008