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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:
06 March - 27 June 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted in accordance with International guidelines and GLP. All guideline validity criteria were met.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Commission Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau
Version / remarks:
24 November 2000
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetraesters of pentaerythritol with 2-methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid
EC Number:
813-120-0
Cas Number:
1262967-45-2
Molecular formula:
C21H36O8 C26H46O8 C31H56O8 C36H66O8 C41H76O8
IUPAC Name:
Tetraesters of pentaerythritol with 2-methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid
Test material form:
liquid
Specific details on test material used for the study:
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark and under nitrogen.
- Stability under test conditions: Asumed stable.
- Solubility and stability of the test substance in the solvent/vehicle: Applied as supplied.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: N/A
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid: N/A

FORM AS APPLIED IN THE TEST (if different from that of starting material): Applied as supplied.

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable): N/A

OTHER SPECIFICS: No

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Stock supply
- Age at study initiation: 3.38-4.48 kg
- Weight at study initiation: 35-37 weeks
- Housing: Each animal was housed individually in a plastic cage with perforated floors.
- Diet (e.g. ad libitum): 125 g of a standard laboratory rabbit diet per day.
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 10 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20 ºC
- Humidity (%): 40-70 %
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12:12 ( light: dark)

IN-LIFE DATES: From: 11 March 2012 To: 23 March 2012

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
Duration of treatment / exposure:
Test item not washed from eye
Observation period (in vivo):
72 h
Duration of post- treatment incubation (in vitro):
N/A
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not conducted
- Time after start of exposure: N/A

SCORING SYSTEM: Kay and Calandra (1962)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
6
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: N/A
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: N/A
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: N/A
Remarks on result:
no indication of irritation
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period.

Injection of the conjunctival blood vessels and moderate discharge were apparent in all treated eyes one hour after instillation. Conjunctival injection persisted in one case until the 48 hour assessment. The treated eyes of two animals were overtly normal 24 hours after instillation and the third animal was overtly normal 48 hours later.

Instillation of the test material gave rise to practically no initial pain response.

Any other information on results incl. tables

Table 1       Mean irritation scores after instillation of Tetraesters of pentaerythritol with 2- methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid

 

Area of eye

1 h

24 h

48 h

72 h

Cornea

0.0

0.0

0.0

0.0

Iritis

0.0

0.0

0.0

0.0

Conjunctiva

6.0

0.7

0.7

0.0

Total mean score

6.0

0.7

0.7

0.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The highest total mean score was 6.0 occurring at the one-hour observation; accordingly under the criteria Kay and Calandra (1962) Reaction product of 3,5,5-trimethyl-hexanoic acid and 2-metheylpropanoic acid and pentaerythritol was classified as “minimally irritating” to the eye. Tetraesters of pentaerythritol with 2- methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid does not require labelling in accordance with European Commission Regulation 1272/2008.
Executive summary:

OECD 405 (2012) - In a primary eye irritation study (OECD 405), undiluted Tetraesters of pentaerythritol with 2-methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid was instilled into the conjunctival sac of the right eye of three female New Zealand White rabbits. The left eye was left untreated. Neither eye was washed during the course of the test. Animals were then observed at 1, 24, 48 and 72 hours. Irritation was scored by the method of Kay and Calandra (1962).

 

There was no sign of toxicity or ill health in any rabbit during the observation period. Injection of the conjunctival blood vessels and moderate discharge were apparent in all treated eyes one hour after instillation. Conjuctival injection persisted in one case until the 48 h assessment. The treated eyes of two animals were overtly normal 24 h after instillation and the third animal was overtly normal 48 h later. Instillation of the test item gave rise to practically no initial pain response.

 

The highest mean score was 6.0, occurring at the 1 h observation (for conjunctiva). This was fully reversed by the 72 h timepoint in all animals.

 

Tetraesters of pentaerythritol with 2-methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid does not require classification or labelling in accordance with EC Commission Regulation (No.) 1272/2008.