Registration Dossier

Diss Factsheets

Administrative data

Description of key information

DPGDB was found to be not irritating or corrosive to eyes or skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study performed
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 July 1997 - 20 July 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture Forestry and Fisheries Requirements for Safety Evaluation of Agricultural Chemicals and Testing Guidelines for Toxicology Studies, Acute Dermal Irritation Study 59 NohSan No. 4200 Agricultural Production Bureau Jan 28 1985
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Interfauna (UK) Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 10 to 12 weeks.
- Weight at study initiation: 2.4 to 2.8 kg
- Housing: Individually housed in metal cages with perforated floors
- Diet: access to SDS Stanrab (P) SQC Rabbit diet (ad libitum)
- Water (e.g. ad libitum): access to mains drinking water (ad libitum)
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 to 21.5°C
- Humidity (%): 57 to 74%
- Air changes (per hr): 19
- Photoperiod: 12 hrs dark / 12 hrs light

- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light per 24 hour period


IN-LIFE DATES: From: 17 July 1997 To: 20 July 1997
Type of coverage:
semiocclusive
Preparation of test site:
other: Hair removed with electric clippers
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: 25 x 25 mm
- Type of wrap if used: Semi-occlusive gauze pad.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment site washed with physiological saline.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Consistent with the scoring system described in OECD test guideline 404.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: All time points (1, 24, 48 and 72 hours after exposure)
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: All time points (1, 24, 48 and 72 hours after exposure)
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No dermal reaction to treatment was observed in any animal throughout the study
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occlusive application of DPGDB to intact rabbit skin for four hours elicited no dermal reaction..
Executive summary:

A study was performed to assess the skin irritation potential of DPGDB to the rabbit. The study was conducted in accordance with OECD, EC, US EPA and Japanese test guidelines, and in compliance with GLP.

Approximately 0.5 mL of the test substance was applied under a semi-occlusive gauze pad to 6 rabbits;  after a period of 4 hours the application site was washed with physiological saline. The animals were then observed for a period of 72 hours.

No dermal reactions were observed following this single semi-occlusive application of DPGDB to intact rabbit skin for four hours.

There were no signs of toxicity or ill health in any of the rabbits during the observation period.

Therefore DPGDB is not irritating to the skin and is not considered to be a primary skin irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
in vivo study performed
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 July 1997 - 26 July 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Note - study report refers to the guideline as number 404 "Acute Eye Irritation / corrosion", adopted 24 February 1987.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF, Requirements for Safety Evaluation of Agricultural Chemicals and Testing Guidelines for Toxicology Studies, Primary Eye Irritation Study, 59 NohSan No 4200, Agricultural Production Bureau, January 28, 1985.
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 10 to 13 weeks.
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet : SDS Stanrab (P) SQC Rabbit Diet, provided ad libitum
- Water: mains drinking water provided ad libitum
- Acclimation period: 18 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 to 21.5°C
- Humidity (%): 50 to 74%
- Air changes (per hr): 19 hours
- Photoperiod: 12 hours artificial light per 24 hour period


IN-LIFE DATES: From: 21 July 1997 To: 26 July 1997
Vehicle:
unchanged (no vehicle)
Controls:
other: The eye contralateral to the treated eye remained untreated in each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL



Duration of treatment / exposure:
Not applicable - a single instillation of test substance was made with no subsequent washing.
Observation period (in vivo):
3 days (observations made 1, 24, 48, and 72 hours after instillation).
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: The scoring system used is consistent with that described in OECD test Guideline 405.


TOOL USED TO ASSESS SCORE: handheld light
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: all animals
Time point:
other: Mean scores (24, 48 and 72 hours)
Score:
0.11
Max. score:
0.33
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal: all animals
Time point:
other: Mean scores (24, 48 and 72 hours)
Score:
0.11
Max. score:
0.33
Irritation parameter:
cornea opacity score
Basis:
animal: all animals
Time point:
other: All time points
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: all animals
Time point:
other: All time points
Score:
0
Max. score:
0
Irritant / corrosive response data:
Instillation of DPGDB into the rabbit eye did not elicit a positive response according to the established test criteria.
A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation.
Other effects:
There were no signs of ill health in any rabbit during the observation period.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Instillation of DPGDB into the eye of the rabbit did not elicit a positive response according to the established test criteria.
A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation.
Executive summary:

A study was performed to assess the eye irritation potential of DPGDB to the rabbit. The study was conducted in accordance with OECD, EC, US EPA and Japanese test guidelines, and in compliance with GLP.

Approximately 0.1 mL of the test substance was instilled into one eye of 6 rabbits, and the effects observed for 72 hours. The eyes were not rinsed after instillation of the test material.

Transient hyperaemia of blood vessels only was observed in all animals. These reactions had resolved in all instances by one or two days after instillation. No corneal damage or iridial inflammation was observed.

There were no signs of toxicity or ill health in any of the rabbits during the observation period.

Instillation of DPGDB into the rabbit eye did not elicit a positive response according to the established test criteria.

DPGDB is not irritant to the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

A study was performed to assess the skin irritation potential of DPGDB to the rabbit. The study was conducted in accordance with EPA, OECD, EC, and Japanese test guidelines, and in compliance with GLP (HLS 1998, VCL 257/973171/SE).

No dermal reactions were observed following a single semi-occlusive application of DPGDB to intact rabbit skin for four hours. DPGDB is not irritating to the skin.

A second study supports this result(International Research and Development Corporation 1975, report 163-341): 3 males & 3 females rabbits were tested (with intact skin and with abraded skin). Very slight erythema was observed in all abraded animals and two animals with skin intact at the end of the observation period. No edema was observed in any animal at any timepoint. DPGDB was not considered to be a primary skin irritant.

 

Eye irritation

An assessment of the potential of the test material DPGDB to cause eye irritation in rabbits was performed, according to EPA, OECD, EC, and Japanese test guidelines, and in compliance with GLP (HLS 1998, VCL 258/973243/SE).

0.1 mL of DPGDB was instilled into one eye of six healthy adult rabbits, and the effects observed for three days (72h). A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation. These reactions had resolved in all instances by one or two days after instillation. No corneal damage or iridial inflammation was observed.

DPGDB was considered as non-irritant for the eye.

 

A second study supports this result (International Research and Development Corporation 1975, 163-341):An assessment of the potential of the test material DEGDB to cause eye irritation in rabbits was undertaken, not formally to any official test guidelines but was similar to OECD 405, although in all animals the eyes were washed, either after 5 minutes or 24 hours.

For animals with 24 hours exposure, slight conjunctival redness was seen in one out of three rabbits one hour and 48 hours after exposure, in two out of three 72 hours after exposure, reverting to one out of three animals after 7 days. For animals with 5 minutes exposure, the results were broadly in line with those for the longer exposure time. No redness was observed at the end of the 7 day observation period.

No corneal damage was seen in any of the animals tested. On the basis of the results obtained, DPGDB would not be considered an eye irritant.

Justification for classification or non-classification

Studies undertaken on DPGDB show that it is not irritating to skin or eyes and as as such is not classified.

Categories Display