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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No guideline followed, not in compliance with GLP. No data on test substance properties (as volatility). Study conducted according to acceptable scientific conditions. Number of tested animals, applied dose, observation time and observed parameters are acceptable.
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No guideline followed, not in compliance with GLP. No data on test substance properties (as volatility). Study conducted according to acceptable scientific conditions. Number of tested animals, applied dose, observation time and observed parameters are acceptable.
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:
conjunctivae score
Basis:
animal #1
Remarks:
- Mean individual score
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3 - Mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicale
Irritation parameter:
chemosis score
Basis:
other: mean individual score for all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: Mean individual score for all animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: Mean individual score for all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Irritant effects on conjunctiva (redness) were minimal at 1 hour in all animals. Redness was fully reversed at 24h in two animals and at 48h in the last rabbit. There were no effects on the cornea and the iris at any time point. Chemosis was not observed at any time point in all animals.
It can be concluded that BP Solvent IH/Isohexadecane would not be classified as eye irritant.
Other effects:
There were no pathological modifications on the deeper eye sections that were checked (cornea, anterior chamber, iris, vitreous body, eye background).

No additional data

Interpretation of results:
other: Not irritating
Remarks:
Migrated information
Conclusions:
under the test conditions, BP Solvent IH/Isohexadecan 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 Isohexadecane based on analogue read across.

The irritant potential of the substance BP Solvent IH/Isohexadecane was assessed by applying 0.1 mL of the test substance in the conjunctival sac of the left eye of 6 male Himalayan rabbits. After application the animals lid were kept closed for 1 second. The right eye was used as control and received 0.1 mL of physiological NaCl solution.

The eyes were examined and the changes were graded according to a numerical scale at 15 min, 1, 24, 48 and 72 hours after dosing.

No conjunctival chemosis, corneal and iridal lesion were observed throughout the observation period. Slight redness of the conjunctivae was observed in all animals at 1 hour but only in one animal by the 24 hours after instillation. At 48-hour observation period, no redness was observed in any rabbit. Hence, the mean individual score for redness was 0.33-0.0-0.0.

BP Solvent IH/Isohexadecane is not classified as eye irritant 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:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Guideline principles
GLP compliance:
not specified
Remarks:
study conducted before GLP principles

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,4,4,6,8,8-heptamethylnonane
EC Number:
224-506-8
EC Name:
2,2,4,4,6,8,8-heptamethylnonane
Cas Number:
4390-04-9
Molecular formula:
C16H34
IUPAC Name:
2,2,4,4,6,8,8-heptamethylnonane
Details on test material:
- Name of test material (as cited in study report): BP Solvent IH/Isohexadecan
- Substance type: petroleum product, UVCB
- Analytical purity : 100% commercial product

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: own Livestock
- Age at study initiation: no data
- Weight at study initiation: between 2.5 and 2.8
- Housing: alone in V2A Steelcage. (floor surface= 0.4 m2)
- Diet (e.g. ad libitum): artificial prepared KF-G 774 ad libitum
- Water (e.g. ad libitum): tap water, ad libitum.
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 60 ± 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12 (150 Lux)


IN-LIFE DATES: July 1980

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye of the treated animals was used as control and received 0.1 mL NaCl physiological solution
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL BP solvent IH/Isohexadecan
- Concentration (if solution):

VEHICLE
no vehicle
Duration of treatment / exposure:
Lids were kept closed for 1 second and then the animals were set free.
Observation period (in vivo):
15 min, 1, 24, 48, 72 hours and 7 days after application
Number of animals or in vitro replicates:
6 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: grading according to OECD 405 recommendation, scoring according to Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
- Mean individual score
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3 - Mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicale
Irritation parameter:
chemosis score
Basis:
other: mean individual score for all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: Mean individual score for all animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: Mean individual score for all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Irritant effects on conjunctiva (redness) were minimal at 1 hour in all animals. Redness was fully reversed at 24h in two animals and at 48h in the last rabbit. There were no effects on the cornea and the iris at any time point. Chemosis was not observed at any time point in all animals.
It can be concluded that BP Solvent IH/Isohexadecane would not be classified as eye irritant.
Other effects:
There were no pathological modifications on the deeper eye sections that were checked (cornea, anterior chamber, iris, vitreous body, eye background).

Any other information on results incl. tables

No additional data

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Migrated information
Conclusions:
under the test conditions, BP Solvent IH/Isohexadecan 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 irritant potential of the substance BP Solvent IH/Isohexadecane was assessed by applying 0.1 mL of the test substance in the conjunctival sac of the left eye of 6 male Himalayan rabbits. After application the animals lid were kept closed for 1 second. The right eye was used as control and received 0.1 mL of physiological NaCl solution.

The eyes were examined and the changes were graded according to a numerical scale at 15 min, 1, 24, 48 and 72 hours after dosing.

No conjunctival chemosis, corneal and iridal lesion were observed throughout the observation period. Slight redness of the conjunctivae was observed in all animals at 1 hour but only in one animal by the 24 hours after instillation. At 48-hour observation period, no redness was observed in any rabbit. Hence, the mean individual score for redness was 0.33-0.0-0.0.

BP Solvent IH/Isohexadecane is not classified as eye irritant according to Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.