Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
06 July 1992 - 21 July 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted to OECD test guidelines, and a statement of GLP compliance was included.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
4: rabbits used
GLP compliance:
yes
Remarks:
Report states that the testing laboratory, Scantox, was accredited by the Danish Accreditation Scheme, however a formal certificate of accreditation was not included.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CTF
- Physical state: A clear, colourless liquid
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Purity test date: Not reported
- Lot/batch No.: 9201
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
- Other:
A read across is proposed based on structural similarities between the substances.

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Møllegard Breeding Centre ApS, Ejby, DK-4623 Lille Skensved.
- Age at study initiation: Not detailed
- Weight at study initiation: 2.5 - 2.7 kg.
- Housing: Animals were kept in single PPL cages, 45 x 55 cm, with perforated floor.
- Diet (e.g. ad libitum): The rabbits had free access to food pellets "Altromin 2123"
- Water (e.g. ad libitum): Free access to drinking water acidified with hydrochloric acid, to pH 2.5.
- Acclimation period: At least one week.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light (from 6h until 18h)


IN-LIFE DATES: From: 06 July 1992 To: 21 July 1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (neat test substance).

Duration of treatment / exposure:
Single exposure.
Observation period (in vivo):
14 days (observations made 1, 24, 48, and 72 hours after exposure, and on days 7 and 14).
Number of animals or in vitro replicates:
Four females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data.

SCORING SYSTEM: Broadly consistent with the system described in OECD test guideline 405.


TOOL USED TO ASSESS SCORE: Hand held inspection lamp fitted with white and UV-light and a magnifying glass, and fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(Cornea opacity)
Basis:
mean
Time point:
other: Mean of 24, 48, and 72 hour timepoints
Score:
1.75
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean of 24, 48, and 72 hour timepoints
Score:
0.08
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Remarks:
(Oedema of conjunctivae)
Basis:
mean
Time point:
other: Mean of 24, 48, and 72 hour timepoints
Score:
2.08
Max. score:
3
Reversibility:
fully reversible within: 14 days.
Irritation parameter:
conjunctivae score
Remarks:
(Redness)
Basis:
mean
Time point:
other: Mean of 24, 48, and 72 hour timepoints
Score:
2.83
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
At the 1 hour reading slight reactions were observed in the cornea and well defined reactions of the coujunctiva (chemosis, redness and discharge) in all the rabbits. The iris were not affected in any of the rabbits. At the 24 hour reading the reactions of conjucntiva had slightly aggravated and the reactions of conjunctiva were unchanged. At the following 48 and 72 hour readings slight to well defined reactions were observed in the cornea and slight to moderate reactions were observed in the conjunctiva. A slight reaction was observed in the iris of one rabbit at the 48 hour readiug. On day 7 slight reactions were observed in the cornea of all the rabbits and slight reactions were observed in the conjunctiva of three rabbits. In one rabbit the conjunctiva appeared normal.
On day 14, the eyes of all 4 rabbits appeared normal.
Other effects:
conjunctival discharge was seen in all aninals at up to 72 hours.

Any other information on results incl. tables

On day 14 the eyes of all rabbits apppeared normal. It was therefore concluded that the eye changes induced by the treatment were reversible, and the study was terminated.

Individual irritation scores

Observation

1h

24h

48h

72h

Mean (24-72h)

7d

14d

Cornea

Opacity

2,1,1,1

2,2,2,2

2,1,2,2

2,1,1,2

1.75

1,1,1,1

0,0,0,0

Iris

Lesion

00,0,0,

0,0,0,0

0,0,0,1

0,0,0,0

0.08

0,0,0,0

0,0,0,0

Conjunctivae

Erythema

3,2,2,3

3,3,3,3

3,2,3,3

3,2,3,3

2.83

1,0,1,1

0,0,0,0

Chemosis

2,2,2,3

3,2,2,2

3,2,2,2

2,1,2,2

2.08

1,0,1,1

0,0,0,0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It was concluded that the test substance CTF should be classified as an eye irritant (Category 2) under CLP.
Executive summary:

A study was performed by Scantox, Denmark, on behalf of Perstorp Polyols, Sweden (subcontracted through Toxicon AB, Sweden), to determine the potential for eye irritation of the test substance CTF. The study was conducted to GLP and according to OECD Test Guideline 405. The test substance was instilled in the eyes of four rabbits, and observations were taken shortly after exposure, and after 24, 48, and 72 hours, and 7 and 14 days. Slight to moderate reactions were seen at 24, 48, and 72 hours, slight reactions were observed at 7 days, and no reactions were seen at 14 days. It was concluded that the test substance CTF should be classified as irritating to eyes. On this basis, it can be concluded that CTF is assigned the symbol Xi and the risk-phrase R36 "Irritating to eyes" according to Directive 67/548/EEC. It is assigned the pictogram GHS07 with the signal word warning and the hazard statement H319 "causes serious eye irritation".