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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:
72 hours (treatment/observation: October 1, 1991 to October 4, 1991).
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A reliability rating of K2 was given due to minor deficiencies e.g., non-inclusion of CAS number and the Certificate of Analysis of the test material in the Study Report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Di-(4-Methylbenzoyl)-peroxid (INTEROX PMBP)
IUPAC Name:
Di-(4-Methylbenzoyl)-peroxid (INTEROX PMBP)
Constituent 2
Chemical structure
Reference substance name:
Bis(4-methylbenzoyl)peroxide
EC Number:
407-950-9
EC Name:
Bis(4-methylbenzoyl)peroxide
Cas Number:
895-85-2
Molecular formula:
C16H14O4
IUPAC Name:
bis(4-methylbenzoyl)peroxide
Test material form:
other: Solid, white
Details on test material:
- Name of test material (as cited in study report): Di-(4-Methylbenzoyl)-peroxid (INTEROX-PMBP)
- Physical state: solid, white
- Analytical purity: Water damped powder 72% PMBP
- Purity test date: Not provided
- Batch No.: IR 240001
- Stability of test article: Stable
-Expiration date: November, 1991
- Stability of test article dilution: Stable
- Storage condition of test material: In the original container; protected from light at room temperature (approx. 20 degrees C)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
IN-LIFE DATES:
Acclimatization: September 27 to 30, 1991
Treatment/Observation: October 1 to 4, 1991
Termination: October 4, 1991
Reported: October 24, 1991

Test System: Rabbit, ChbbIbm: NZW (SPF)
Rationale: Recognized by the international guidelines as the recommended test system (e.g. OECD, EEC).
Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, CH-4414, Fullinsdorf
Number of animals: 1 male, 2 females
Age at start of treatment: male: 15 weeks; females: 16 weeks
Body weight at start of treatment: male: 2.9 kg; females: 2.9 - 3.0 kg
Identification: By unique cage number and corresponding ear tags.
Acclimatization: Four days under test conditions after veterinary examination.
Allocation: Animal Numbers, Male no. 34, and Female nos. 35 – 36

Standard Laboratory Conditions.
Air-conditioned with 10-15 air changes per hour and hourly monitored environment with a temperature of 20±3 degrees centigrade, a relative humidity between 40-70% (values above 70% during cleaning process possible), 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark, music during the light period.

Accommodation
Individually, in stainless steel cages (size: 35.5 x 55.5 x 45 cm) equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, 0-7830 Emmendingen).

Diet
Pelleted standard Kliba 341, Batch 63/91 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum. Results of analysisfor contaminants are included in the original study report.

Water
Community tap water from Itingen, ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the original Study report.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye of each animal remained untreated and served as the reference control
Amount / concentration applied:
0.1 g of the test article (undiluted)
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
Rationale: Ocular contact is one of the probable routes of human exposure.

TREATMENT: The eyes of the animals were examined once, one day prior to test article administration. Only those animals with no signs of ocular injury or irritation were used on the test. On test day 1, 0.1 g of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission Washington, D.C. 20207 was used for additional control purposes.

Viability/Mortality and Clinical Signs**: Daily.

Body Weights: At the start of acclimatization, at day 1 of test (application day) and at termination of observation.

** Viability/mortality was recorded together with clinical signs on-line at the
same time intervals. It is not specifically indicated in the computer system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
(Mean)
Basis:
mean
Remarks:
of animals # 34M, 35F & 36F
Time point:
other: 1 hr
Score:
1.67
Irritation parameter:
overall irritation score
Remarks:
(Mean)
Basis:
mean
Remarks:
of animals # 34M, 35F & 36F
Time point:
other: 24 hrs
Score:
0.67
Irritation parameter:
overall irritation score
Remarks:
(Mean)
Basis:
mean
Remarks:
of animals # 34M, 35F & 36F
Time point:
other: 48 hrs
Score:
0
Irritation parameter:
overall irritation score
Remarks:
(Mean)
Basis:
mean
Remarks:
of animals # 34M, 35F & 36F
Time point:
other: 72 hrs
Score:
0

Any other information on results incl. tables

RESULTS

 

VIABILITY / MORTALITY AND CLINICAL SIGNS:

No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred.

 

IRRITATION:

Di-(4-Methylbenzoyl)-peroxid (INTEROX-PMBP) showed a primary irritation score

of 0.58, when applied to the conjunctival sac of the rabbit eye.

 

COLORATION:

In the area of application no staining of the cornea and conjunctivae by pigment or coloring of the test article was observed.

 

CORROSION:

Generally slightly diffuse corneal opacity was observed in one animal (female

no. 36) in the first hour after test article application.

 

BODY WEIGHTS:

The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test article, Di-(4-Methy1benzoyl)-peroxid (INTEROX-PMBP), had to be classified as not irritant to the rabbit eye.
Executive summary:

SUMMARY

The purpose of this primary eye irritation study was to assess the possible irritation potential when a single dose of Di-(4-Methylbenzoy1)-peroxid (INTEROX-PMBP) was placed in the conjunctival sac of NZW rabbit eyes. This study should provide a rational basis for risk assessment in man. This GLP study was conducted according to OECD 405 and EEC B5 test guidelines. A reliability rating of K2 was given due to minor deficiencies such as the lack of inclusion of CAS number and the Certificate of Analysis of the test material in the study report.

 

According to EEC Council Directive, 83/467/EEC, July 1983 and 67/548/EEC, May 1987, Brussels, Belgium, the mean value of the scores for each type of lesion, calculated for each animal separately, is the following:

 

Animal                              Mean values 24 - 72 hours         

No.                  Cornea            Iris                                   Conjunctivae

opacity                                             Redness         Chemosis        

34 M               0.00                0.00                             0.33                      0.00     

35 F                0.00                0.00                             0.00                      0.00     

36 F                0.00                0.00                             0.33                      0.00    

 

Mean cumulative score: 0.22; Primary irritation score: 0.58 (mean of 24, 48, and 72 hr scores)

Under the conditions of this GLP-certified experiment, Di-(4-Methylbenzoyl)-peroxid was found to cause a primary irritation score of: 0.58 when applied to the conjunctival sac of the rabbit eye. No staining of the cornea and conjunctivae of the treated eyes by pigment or coloring of the test article was observed. Generally slightly diffuse corneal opacity was observed in one animal (female animal No. 36) in the first hour after test article application. Body weight gain of all rabbits was similar.

Conclusion: Due to the results described above, the test article (Di-(4-Methy1benzoyl)-peroxid (INTEROX-PMBP) had to be classified as not irritant to the rabbit eye.

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