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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to GLP and sufficient data is available for interpretation of results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Untreated DPE 75 (XZ 95510)
- Distillate containing 75% diphenylethane (DPE)
- Physical state: Clear, very pale straw-colored liquid
- Storage condition of test material: Room temperature
- Source: Dow Chemical Europe S.A.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three New Zealand White rabbits were used for the study. The animals were individually housed in suspended metal cages in a single room maintained at a temperature of 17 to 23°C and relative humidity of 40 to 70%. Artificial lighting provided 12 -hours light and 12 hours darkness. The animals were acclimatised for at least three days before treatment and individually identified by an indelible number written on the inner surface of the ear andby cage label.

The animals were allowed free access to food (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK) and water.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: No, the untreated eye served as the control.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Single application
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Three New Zealand White rabbits were used for the study. The animals will be held firmly but gently until quiet. The test material was placed into the eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup. For liquids the quantity administered was 0.1
ml. The untreated eye served as a control.

Assessment of ocular irritation was made 1, 24, 48 and 72-hours after treatment using the Draize Scal . A descriptive rating and
class of irritation was obtained using a modified system described by Kay J.H. and Calandra J.C., J. Soc. Cosmet. Chem. 1962, 13 281 - 289.

If irritation was present at the 72-hour observation a further reading was made on day 7.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Dulling of cornea surface in 2 of 3 rabbits. The 3rd rabbit was scored a 0.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
other: Conjunctivae- Redness
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: Conjunctivae-Redness
Basis:
mean
Time point:
other: 24 hour
Score:
0.67
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Conjunctivae- Redness
Basis:
mean
Time point:
other: 48 hour
Score:
0.33
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Conjunctivae-Redness
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Conjunctivae- Chemosis
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: Conjunctivae-Chemosis
Basis:
mean
Time point:
other: 24 hour
Score:
0.33
Max. score:
4
Reversibility:
not specified
Irritation parameter:
other: Conjunctivae-Chemosis
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
other: Conjunctivae-Chemosis
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
other: Conjunctivae-Discharge
Basis:
mean
Time point:
other: 1 hour
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
other: Conjunctivae-Discharge
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Conjunctivae-Discharge
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Conjunctivae-Discharge
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
3
Reversibility:
not specified
Irritant / corrosive response data:
A dulling of the normal lustre of the cornea was observed in two treated eyes at the one hour reading only. No evidence of corneal irritation was
apparent at the 24-hour reading in these two treated eyes or in the remaining treated eye throughout the study period.

No evidence. of iridial inflammation was observed in any treated eye throughout the study period.

Moderate conjunctival irritation manifested as redness and chemosis was observed in all three treated eyes at the one hour observation. This
irritation regressed and had ameliorated completely in one treated eye at the 24-hour reading, in a further treated eye at the 48-hour reading and in
the remaining treated eye at the 72-hour observation. The test material produced a maximum mean score of 8.7 and was regarded as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye by a modified Kay and Calandra scoring scale.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye. However according to the CLP and DSD criteria this substance is not considered to be irritant to the eyes.
Executive summary:

Untreated DPE 75 (75% diphenyl ethane), a potential thermal oil, was provided for toxicity, testing by the Olefin Derivatives Department, DCE.

Eye irritation studies were performed with 3 New Zealand White rabbits in each case. Instillation of 0.1 m l into the eye resulted in transient corneal dulling. There was some conjunctival.irritation which had resolved 48 hours after treatment. This paterial was allocated to class 4 (on a 1-8 scale) by a modified Kay and Calandra scoring system and is considered a mild eye irritant.