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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Consumer Product Safety Commision USA (Code of Federal Regulations, Title 16, Section 1500.42)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzene-1,3,5-tricarboxylic acid
EC Number:
209-077-7
EC Name:
Benzene-1,3,5-tricarboxylic acid
Cas Number:
554-95-0
Molecular formula:
C9H6O6
IUPAC Name:
benzene-1,3,5-tricarboxylic acid
Test material form:
solid
Details on test material:
Benzene-1,3,5-tricarboxylic acid manufactured by Chemische Werke Hüls AG Marl (1980)

Test animals / tissue source

Species:
rabbit
Strain:
other: White New Zealand
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: White New Zealand
- Sex: male and female
- Source: J. Scheele, Büderich (Germany)
- Number of animals: 3 males, 3 females

ENVIRONMENTAL CONDITIONS
- Feed: Ssniff K 4 (Ssniff, Soest; Germany)
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Illumination: 12 hour light/dark rhythm

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- undiluted
- Amount applied: 0.1 ml
- Controls: untreated eye
Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
 Ophtalmoscopic examination:  24, 48, 72 hours, 7 days after treatment
Number of animals or in vitro replicates:
6
Details on study design:
EXAMINATIONS
- Ophtalmoscopic examination:  24, 48, 72 hours, 7 days after treatment
- Scoring system: Draize (1959)
- Tool used to assess score: Na fluorescein / ophthalmic lamp / visual  inspections

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48, 72 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.55
Max. score:
20
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.11
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Irritation Score = 0.67
Conjuntivae score = 0.55
Chemosis score = 0.11
Other effects:
no other effects

Applicant's summary and conclusion

Conclusions:
According to the outcome of the study in rabbits slight and reversible conjunctival effects (redness and swelling) were noted in this study.
Executive summary:

In a primary eye irritation study 0.1 mL of undiluted test item was instilled into the conjunctival sac of one eye of three male and three female young adult White New Zealand rabbits. Eyes were not rinsed. Animals were observed for 7 days. 

After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein.

Reactions were scored according to the Draize-Score.

Slight reversible conjunctival effects were observed. 24 hours after administration five animals showed slight redness and one animal showed a slight swelling above normal. Cornea and iris were not affected.

Irritation Score = 0.67