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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:
30 May to 6 June 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline N°405 but not in compliance with GLP. Substance analytical certificate provided by the manufacturer
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
30 May to 6 June 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline N°405 but not in compliance with GLP. Substance analytical certificate provided by the manufacturer
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
individual scores in all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: See Table 1 for details
Irritation parameter:
iris score
Basis:
mean
Remarks:
individual scores in all animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: See Table 1 for details
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 mean individual score
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 hours
Remarks on result:
other: See Table 1 for details
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: See Table 1 for details
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 hours
Remarks on result:
other: See Table 1 for details
Irritation parameter:
chemosis score
Basis:
animal: #2, #3 mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: See Table 1 for details
Irritant / corrosive response data:
No corneal damage or iridal inflammation was observed. A diffuse crimson-red coloration of the conjunctivae was only observed in two animals one hour after instillation. Temporary mild conjunctival irritation was noted in the third animal. The eyes were normal 48 hours after instillation in all rabbits.
Other effects:
No other lesions

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

24 h

0/0/0

0/0/0

1/1/0

1/0/0

48 h

0/0/0

0/0/0

0/0/0

0/0/0

72 h

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0.0-0.0-0.0

0.0-0.0-0.0

0.33-0.33-0.0

0.33-0.0-0.0

Reversibility*)

-

-

48 h

48 h

Average time (unit) for reversion

-

-

c

c

*)Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Petrepar-147 is not classified as eye irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
Executive summary:

This data is being read across from the source study that tested Hydrocarbons, C14-C17, n-alkanes, <2% aromatics based on analogue read across.

The eye irritant effect of Petrepar-147 was investigated according to the OECD Guideline No. 405 (1981).

Three albino rabbits were exposed to 0.1 mL of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 78 hrs and on day 4 and 7 after dosing. The eyes were not rinsed after administration of the test substance.

No corneal damage or iridal inflammation was observed. Redness and chemosis were observed in all animals, one hour after instillation. Slight redness was still observed in two animals at 24 hours while slight chemosis was only observed in one rabbit. The eyes of all rabbits were normal 48 hours after instillation. The mean individual scores were 0.33/0.33/0.0 for conjunctival redness and 0.33/0.0/0.0 for chemosis.

Petrepar-147 is not considered as irritating to the eyes according to Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Guideline study
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C14-C17, n-alkanes, <2% aromatics
EC Number:
917-828-1
Molecular formula:
none available - not a single isomer - see remarks
IUPAC Name:
Hydrocarbons, C14-C17, n-alkanes, <2% aromatics
Constituent 2
Reference substance name:
Petrepar 147 (P-147)
IUPAC Name:
Petrepar 147 (P-147)
Details on test material:
- Name of test material (as cited in study report): Petrepar 147 (P-147)
- Substance type: petroleum product, UVCB
- Physical state: colourless liquid
- Analytical purity: 100 % commercial product
- Composition of test material, percentage of components: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Pemberley Rabbits, Cottenham, Cambridgeshire
- Age at study initiation: approximately 9 to 11 weeks
- Weight at study initiation: 2.1 to 2.5
- Housing: individually in metal cages with perforated floors
- Diet : Free access to SDS Standard Rabbit Diet
- Water : Free access to tap water
- Acclimation period: yes but no data on period


ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained at approximately 19°C
- Humidity (%): maintained at approximately 30-70%
- Air changes: maintained at approximately 19 air changes per hours
- Photoperiod (hrs dark / hrs light): lighting was controlled to give 12 hours of artificial light (07.00-19.00) in each 24 hour period

Test system

Vehicle:
not specified
Controls:
other: the contralateral eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
7 days
Observation period (in vivo):
Examinations at 1, 24, 48, 72 hours and on Day 4 and 7.
Number of animals or in vitro replicates:
3 animals
Details on study design:
SCORING SYSTEM: as prescribed by OECD No 405 guideline

TOOL USED TO ASSESS SCORE: handheld torch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
individual scores in all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: See Table 1 for details
Irritation parameter:
iris score
Basis:
mean
Remarks:
individual scores in all animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: See Table 1 for details
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 mean individual score
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 hours
Remarks on result:
other: See Table 1 for details
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: See Table 1 for details
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 hours
Remarks on result:
other: See Table 1 for details
Irritation parameter:
chemosis score
Basis:
animal: #2, #3 mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: See Table 1 for details
Irritant / corrosive response data:
No corneal damage or iridal inflammation was observed. A diffuse crimson-red coloration of the conjunctivae was only observed in two animals one hour after instillation. Temporary mild conjunctival irritation was noted in the third animal. The eyes were normal 48 hours after instillation in all rabbits.
Other effects:
No other lesions

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

24 h

0/0/0

0/0/0

1/1/0

1/0/0

48 h

0/0/0

0/0/0

0/0/0

0/0/0

72 h

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0.0-0.0-0.0

0.0-0.0-0.0

0.33-0.33-0.0

0.33-0.0-0.0

Reversibility*)

-

-

48 h

48 h

Average time (unit) for reversion

-

-

c

c

*)Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Petrepar-147 is not classified as eye irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
Executive summary:

The eye irritant effect of Petrepar-147 was investigated according to the OECD Guideline No. 405 (1981).

Three albino rabbits were exposed to 0.1 mL of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 78 hrs and on day 4 and 7 after dosing. The eyes were not rinsed after administration of the test substance.

No corneal damage or iridal inflammation was observed. Redness and chemosis were observed in all animals, one hour after instillation. Slight redness was still observed in two animals at 24 hours while slight chemosis was only observed in one rabbit. The eyes of all rabbits were normal 48 hours after instillation. The mean individual scores were 0.33/0.33/0.0 for conjunctival redness and 0.33/0.0/0.0 for chemosis.

Petrepar-147 is not considered as irritating to the eyes according to Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.